Alignment. Sign in to add this product to your favorites! Rethink how you buy and sell surgical supplies. Lehr MA, Oner CF, Delawi D, et al. This is why we show up every day, united and committed to our vision. NuVasive is developing the operating room of the future. The Company will hold a conference call tomorrow, Feb. 25, 2021, at 4:30 p.m. *Data on file. gtag('config', 'G-XBG07ECKJ5'); BOLTS FOR SMALL CAGE COROENT INTERLOCK NUVASIVE, CERVICAL DISC PROSTHESIS CERPASS NUVASIVE, CONNECTOR AND NUT CLOSURE STERILE - VUEPOINT II, COROENT CAGE SMALL SCREW INTERLOCK NUVASIVE, COROENT LARGE OBLIQUE STERILE - CAGE INTERSOMATICO, COROENT SMALL INTERLOCK II - CAGE INTERBODY, COROENT XL TITANIUM BARREN - CAGE INTERBODY, DYNAMIC STIMULATION AND INLINE CLIP APPLICATOR, HOOK AND NUT CLOSURE STERILE - VUEPOINT II, LIVES FOR LATERAL PLATE NEXT GEN DECADE NUVASIVE, NV M5 XLIF KIT WIRE KIRSCHNER AND DILATOR, SCREWS E NUT CLOSURE STERILE - VUEPOINT II, STAPLE FOR LATERAL PLATE NEXT GEN DECADE NUVASIVE, SYSTEM COROENT XL STERILE - CAGE INTERBODY, THE PAS-II PEDICLE INSULATED SYSTEM ACCESS, Complete classification of medical devices. The Company expects the acquisition to accelerate net sales growth and be accretive to non-GAAP diluted earnings per share in 2022. For more information, please visit www.nuvasive.com. The dial-in numbers are 1-800-954-0604 for domestic callers and 1-312-281-1210 for international callers. NuVasive is the fastest growing, full-line spine company. Bone Preparation & Cement Application Kits, Balloon Dilatation Catheters Insertion Kits, Skip to the beginning of the images gallery. Prices (minimum order quantity 10 pieces)10 - 25- 64,9026- 50 - 61,60more than 50pieces - pleasecontact usfor a new quote. In an effort to evolve the standard of care for early-onset scoliosis (EOS) and adolescent deformity patients, we have invested in a comprehensive product portfolio that introduces surgical efficiencies and optimized implant constructs, and we remain committed to supporting the progression of clinical education and scientific research in this space. Build the strongest argument relying on authoritative content, attorney-editor expertise, and industry defining technology. The cervical segment of the global spine market represents a $2.6 billion opportunity, and the Company is well-positioned to expand its reach with the addition of the Simplify Disc to its C360 portfolio. Alignment Matters . To learn more, visit www.simplifymedical.com. Excluding VAT and shipping. Nov 15 (Reuters) - Globus Medical Inc (GMED.N) has approached NuVasive Inc (NUVA.O), a U.S. manufacturer of equipment for minimally invasive spine surgery with a market value of $3 billion, with an acquisition offer, people familiar with the matter said. Prices (minimum order quantity 50 pieces)50 - 99 pieces - 8.40100- 250 pieces - 7.50more than 250pieces - pleasecontact usfor a new quote. PDF NuVasive, Incorporated September 26, 2019 Mr. Mark Job Responsible obtained from Document Control, or a reference copy may be viewed on the NuVasive Network Server. Leading Independent Proxy Advisory Firm Glass Lewis Joins ISS in Recommending NuVasive Shareholders Vote "FOR" the Proposed Merger with Globus Medical, Leading Independent Proxy Advisory Firm ISS Recommends NuVasive Shareholders Vote "FOR" the Proposed Merger with Globus Medical, NuVasive to Participate in Upcoming Global Spine Conferences, NuVasive Specialized Orthopedics Expands Indications of Precice Limb Lengthening System to Treat Pediatric Patients. Thu, October 4th, 2018. The NuVasive Biologics portfolio includes procedurally integrated allogeneic bone graft substitutes and extenders, and synthetic ceramic bone graft substitutes intended to promote bone fusion. 18 0 obj << /Filter /FlateDecode /Length 19 0 R >> stream NuVasive offers solutions to alleviate patient symptoms. At this time, the overall benefits of the devices outweigh the known risks for on-label use with the updated labeling, compared to alternative treatments. You have not been assigned a username and password. NuVasive Inc Company Profile - GlobalData function gtag(){dataLayer.push(arguments);} NuVasive provides patient support and surgeon education. Voluntary reports can be submitted through, Device manufacturers and user facilities must comply with the applicable, Health care personnel employed by facilities that are subject to the. Duan R, Barbieri D, Luo X, et al. Prices(minimum order quantity 25 pieces)25 - 49 pieces - 13,8750 - 99 pieces - 8,75100 - 200 pieces - 7,86more than 200 pieces - please contact us for a new quote. Prices excluding VAT and shipping. Peer-to-peer discussion between Drs. At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. hbbd``b`I3@R $eL :X] BDLv ^e a$@@ He`bd^d100H xl westcmrglobal.com |geosurgical.com |wareconsultingllc.com, West Coast Medical Resources | Serving the surgical community since 1997. All quotes delayed a minimum of 15 minutes. Reline 3D, which is an extension to the NuVasive's Reline system, is part of the firm's comprehensive spine fixation portfolio that includes Reline Open, Reline MAS, Reline Trauma and Reline Small Stature. An official website of the United States government, : Before sharing sensitive information, make sure you're on a federal government site. An integrated technology platform to enable better spine surgery. 2. Surgical efficiency. Simplify Medicals technology was designed to offer surgeons best-in-class capabilities for cTDR across key performance functions, including: NuVasive will leverage its commercial and distribution channels in the U.S. and international markets to drive utilization of the Simplify Disc. JavaScript seems to be disabled in your browser. NuVasive has developed the Reline 3D system to offer simultaneous and three-dimensional deformity correction through a simplified procedure. Read the press release All products sold by WestCMR are in-date. We are excited about the opportunities this acquisition creates as we work to optimize the surgeon experience, advance the standard of care, and create value for shareholders.. D. Device Description The NuVasive Sage Lateral Plate System is an anterior/anterolateral plate system that may be used in the thoracic, lumbar, and sacral spine (TI-SI). By using modern education principles, competency-based curriculum, and multi-modal learning pathways, the CPD team and its dedicated surgeon faculty provide an unparalleled learning experience for surgeons and their staff around the globe. Expected delivery: 3 weeks. Indications For Use NUWAVE is a germicide intended to disinfect non-critical medical devices and equipment surfaces including CPAP masks, tubing and water chambers. Osteoinduction of human mesenchymal stem cells by bioactive composite scaffolds without supplemental osteogenic growth factors. Transaction Details The unique microarchitecture of Attrax drives the differentiation of mesenchymal stem cells (MSCs) into bone-forming osteoblasts without added growth factors.2 The optimized microarchitecture of Attrax is engineered using tightly controlled parameters for a defined micropore size distribution within 0.3 to 1.1 microns, demonstrated to initiate greater bone formation compared to traditional ceramics.3, Attrax Putty is one of only a few bone grafting devices on the market supported by a Level I randomized controlled trial as a bone graft substitute in posterolateral spinal fusions.4. Anterior lumbar interbody fusion (ALIF) is a surgical procedure used to treat problems such as disc degeneration, spinal instability, and deformities of the spine. Reimagine cervical spine surgery. List of devices made by the manufacturer NUVASIVE, INC. PDF San Diego, CA 92121 PCM - Food and Drug Administration STRYKER 502-427-030 VIDEO ARTHROSCOPE, 4MM 30 DEG. 5. The discussions between the companies are preliminary and there is no certainty that a deal will be reached, the sources added, requesting anonymity because the matter is confidential. Do not implant in patients under 18 years of age. Simplify Cervical Artificial Disc provides NuVasive most clinically effective technology in the cervical total disc replacement (cTDR) procedure segment, Expands growth opportunities and further differentiates Companys comprehensive portfolio across ACDF, PCF, and cTDR procedures. (Top row): NuVasive DBM putty and gel and NuVasive amniotic membrane DS (Bottom Row): Traditional bone allograft and DBM fibers / Courtesy of NuVasive, Inc. NuVasive, Inc. has announced U.S. commercial launch of three new biologics . Propel DBM is donated human bone that has been demineralized to remove the minerals and cells contained in the bone while retaining the collagen matrix and growth factors, including bone morphogenetic proteins, inherent to the tissue. or more while undergoing treatment, and. NuVasive Company Profile - Office Locations, Competitors, Revenue Tell us something about it and help others to make the right decision, We use UPS, Fedex, USPS and our sellers ship quickly and securely, Customer satisfaction is our top priority, we are not happy until you are happy. Additional risks and uncertainties that may affect future results are described in NuVasives news releases and periodic filings with the Securities and Exchange Commission. Forward-Looking Statements The company offers implants, fixation products, intraoperative monitoring (IOM) services, disposables, and biologics for use in spinal surgery. Follow the actions provided by NuVasive in their, Report any adverse events or suspected events through. As demonstrated by the strong clinical data and the unique design characteristics of the Simplify Disc, we share NuVasives focus on outcome-driven innovation, said David Hovda, president and chief executive officer of Simplify Medical. Osteocel provides a complete and physiologic bone graft that contains all of the necessary components for bone growth: the cells, the signals, and the scaffold. N]1N6xB w4C !~)H-,E niwm"mm1PTkYn|,v]Pch%HjSOfSzuE*o ! Canadian pipeline operator Enbridge Inc said on Monday it would acquire Aitken Creek natural gas storage facility in British Columbia (B.C.) NuVasive is developing the operating room of the future. See here for a complete list of exchanges and delays. RCCmyf(&3Tn@}M S,3c6qr|b2#JQ|%^@ZQTK,1gCTS pD"d(GR ~h'! The materials on this website are for your general educational information only. As an innovator in the TLIF space, NuVasive technology helps deliver an optimized surgical experience from single-level degenerative to multi-level deformity cases. At NuVasive, we transform surgery, advanced care, and change lives. Potential Biocompatibility Concerns with NuVasive Specialized Journal of Neurosurgery Spine. Innovation in Musculoskeletal Solutions | Globus Medical Advisors Simplify Medical is located in Sunnyvale, California. Prices (minimum order quantity 125 pieces)125 - 249- 3,95250 - 500 - 2,90more than 500pieces - pleasecontact usfor a new quote. Spine 2020;45(14):944-51. UPDATE: Potential Concerns with NuVasive Precice Devices The acquisition of Simplify Medical adds the most clinically effective cTDR technology and further distinguishes NuVasives cervical portfolio in the market. var base_url = "https://www.medicaldevices24.com/"; Surgical efficiency meets reliable versatility. NuVasive provides patient support and surgeon education. NuVasive also announced a voluntary recall to notify users of the updated labeling for titanium-based Precice devices listed here. Robert Eastlack and Gregory Mundis. The .gov means its official.Federal government websites often end in .gov or .mil. The materials on this website are for your general educational information only. Published online June 3, 2022; DOI: 10.3171/2022.4.SPINE211070. PLoS ONE 2011;6(10):1-8. Address 7475 Lusk Blvd, San Diego, California, 92121. PDF NuVasive, Incorporated Olga Lewis Director, Regulatory Affairs System Price: $5.00 per kit. Expected delivery: 3 weeks. NuVasive is the fastest growing, full-line spine company. Previously, on April 5, 2021, NuVasive had posted a statement informing health care providers of ongoing biocompatibility testing with Precice devices and placed a global ship hold for all Precice devices. There are no new recommendations regarding the stainless steel-based Precice devices since the July 2021 letter to health care providers. At NuVasive, we transform surgery, advanced care, and change lives. At NuVasive, we aspire to change a patients life every minute. Information you read on this website cannot replace the relationship that you have with your healthcare professional. The contents of this Site, including but not limited to the text and images herein and their arrangements, unless otherwise noted, are the copyrighted material of Oisto. from FortisBC Holdings Inc for C$400 million ($294.68 million). The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with NuVasive Precice devices. Investor Conference Call Prices excluding VAT and shipping. Expected delivery: 3 weeks. PDF User Manual - Nuwave Cpap Neurostimulators & Components. Our Standards: The Thomson Reuters Trust Principles. Retroperitoneal access 3. Expected delivery: 2 weeks. Weve partnered with the worlds leading surgeons to advance cervical surgery and deliver a comprehensive, procedurally integrated portfolio for anterior and posterior cervical proceduresC360. 888 0 obj <>stream Hear from Doug Bireley, Vice President of Global Product Marketing, product leadership, and spine surgeons across the globe. Simplify Medical is a medical device company focused on cervical spinal disc arthroplasty, using innovative, MRI-compatible materials designed to optimize diagnostic imaging and decrease the need for ionizing radiation. The most comprehensive solution to manage all your complex and ever-expanding tax and compliance needs. Information you read on this website cannot replace the relationship that you have with your healthcare professional. Open the catalog to page 2 What is causing my pain? NuVasive provides patient support and surgeon education. NuVasive is headquartered in San Diego, California, the US. Together, we create a comprehensive, procedurally integrated cervical portfolio differentiated by technology and breadth. This can minimize the potential risks while also minimizing the risks associated with repetitive surgical interventions and suboptimal conversion to alternative therapies mid-treatment. Through our shared mindset calledThe Cheetah Way, we show up every day united and committed to do just that. Headquarters United States of America. Check out The Better Way Back, a free patient support program for those suffering from a spinal condition. The San Diego, CA-based company said the RMM incorporates extremely low-profile modular implants and advanced system instrumentation to address alignment and potentially reduce . The materials on this website are for your general educational information only. Ensure patients with a Precice device continue to receive appropriate follow-up monitoring. ALIF - NuVasive Our combined innovative technologies will create differentiated, comprehensive procedural solutions to better support surgeons, healthcare providers and patients. Prices (minimum order quantity 144 pieces)144 pieces - 2,75288 pieces - 2,50more than 500 pieces - pleasecontact usfor a new quote. $1,299.99. Expected delivery: 3 weeks. Malone, H., Mundis, G. M., Jr., Collier, M, et al. The U.S. Food and Drug Administration (FDA) continues to monitor potential biocompatibility concerns associated with NuVasive Specialized Orthopedics Precice devices made from stainless steel and titanium. Prices(minimum order quantity 10 pieces)10 - 24 pieces - 22,6525 - 49 pieces - 19,3050 - 100 pieces - 17,60more than 100 pieces - please contact us for a new quote.Expected delivery: 3 weeks. Product Code: NKB, KWP, MNI, MNH, KWQ C. Predicate Devices The subject Nu Vasive Polyaxial Spinal Screws are substantially equivalent to the PreceptTM (K1025 14), Armada (K092287), and SplzeRx PPS (K090981) Systems currently distributed commercially in the U.S. by NuVasive. Fusion is primarily performed to eliminate the pain often caused by abnormal motion of the vertebrae. We believe in the importance of preoperative decision-making and support toolsinformed by data and clinical experiencepaired with novel, intraoperative tools to execute a surgeon-specific plan. Based on review of publicly available materials at the time of this release. Globus, which is a provider of implantable devices and instruments used in spinal and orthopedic surgeries, made an indicative cash-and-stock offer for NuVasive in recent weeks, the sources said. 50 - 99 pieces - 8,75. var site_url = "https://www.medicaldevices24.com/"; PCF - NuVasive - PDF Catalogs | Technical Documentation Pursuant to the terms of the transaction agreement, NuVasive made an upfront payment to Simplify Medical of $150.0 million at closing, subject to customary purchase price adjustments, and agreed to make additional future payments contingent upon milestones related to regulatory approval and net sales from products incorporating the Simplify Cervical Artificial Disc technology. $650.00. Our team is inspired by the needs of these patients, and the surgeons and health care providers who treat them. All rights reserved. That no more than two devices should be implanted at a time. On April 5, 2021, NuVasive posted a statement informing health care providers of ongoing biocompatibility testing with Precice devices and placed a global ship hold for all Precice devices. Exclusive news, data and analytics for financial market professionals, Reporting by Greg Roumeliotis in New York, US FDA declines to approve Ascendis' hormone disorder therapy, Astellas Pharma buys Iveric Bio for $5.9 billion, Pfizer, BioNTech propose EU pays half for each cancelled COVID dose, Financial Times reports, Indian cough syrup: mystery middleman may be new clue, Enbridge acquires gas storage facility in British Columbia for $295 million, Adani-owned NDTV profit plunges about 98% on weak advertising demand, U.S. FAA opens new direct plane routes ahead of summer travel, Russia temporarily halts gas supply to Armenia for planned maintenance, Norwegian Cruise lifts profit forecast on higher ticket prices, steady demand. D. Device Description. Excluding VAT and shipping. The integration of XLIF, XALIF, and XFixation into a single platform enables surgeons to treat a patient without repositioning, which may reduce patient time under anesthesia and hospital costs. On November 30, 2021, NuVasive issued a field safety notice to inform health care providers of updated labeling and the ship hold in the United States was lifted for titanium-based Precice devices. This reflects the technologys favorable growth and margin profile, combined with NuVasives substantial commercial capability and C360 portfolio integration. Number of products: 188 ACCESS SURGICAL MAXCESS KIT ACCESS SYSTEM MAXCESS ALIF TI INTERFIXATED - BOLTS ALIF TI INTERFIXATED - CAGE Prices (minimum order quantity 10 pieces)10 - 49 pieces - 22,4050 - 100 pieces - 17,20more than 100pieces - pleasecontact usfor a new quote. The FDA continues to work with NuVasive to: The FDA will continue to keep health care providers and the public informed as new or additional information becomes available. 1. 789 0 obj <> endobj iMedSales is a premier surgical and medical equipment supplier that provides a combina Philips L12-5 Linear Probe - 50mm Compact 256-Element Transducer ~ BRAND NEW ~, Storz Hopkins 27015B 30 Degree Cystoscope Good Clean Image, STRYKER 502-427-030 VIDEO ARTHROSCOPE, 4MM 30 DEG, Conmed Linvatec E9010 CoolFlex E9000 High Speed Drill, Karl Storz 22220154 HD Image 1 H3M Microscope, Dr 3-Chip Camera, Karl Storz 20132020 Xenon Light Source 175 Watt ~ Lamp only has 13 hours, Medical Blue Nitrile Gloves Latex Free, Powder Free, Textured, Disposable, Non-Sterile 100 pieces per box of 1. Unhappy? At NuVasive, we transform surgery, advanced care, and change lives. As the innovation leader in spine, our goal is to provide you with comprehensive procedural solutions and enabling technology to change patient lives. All rights reserved. This service located at Oisto.com is a website owned and operated by Oisto. The forward-looking statements contained herein are based on the current expectations and assumptions of NuVasive and not on historical facts. The device is currently being evaluated in a separate IDE study in the U.S. for 2-level indications, pending FDA approval. Biomater Sci 2018;6:136-45. Website www.nuvasive.com. Make sure cookies are enabled in your browser. Additional predicates include: NuVasive Modulus XLIF Interbody System (K163230/K192760), NuVasive Modulus TLIF Interbody System (K172341), NuVasive Foundation-LL System (K152943) and NuVasive CoRoent Lumbar Interbody Implants System (K161230). PDF NVM5 Computer-Assisted Rod Bending It will also discuss the Simplify Medical transaction at that time. NuVasive funded the upfront payment at closing using available cash on hand. Combining the Simplify Disc with NuVasives C360 portfolio will enable us to provide surgeons with world-class cervical technology, regardless of their preferred procedural approach. Product images are for display only.
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