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. 8050015: NuVasive NVM5 EMG Needle ModuleExpired NuVasive NuVasive. In this list are all medical devices registered by the ministry of health that are produced by the manufacturer NUVASIVE, INC. Name: NUVASIVE, INC. 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). If the item is subject to FDA regulation, seller must verify your status as an authorized purchaser of this item before shipping of the item. Alignment. Becoming the number one partner in pediatrics. About NuVasive Peer-to-peer discussion between Drs. if( $robots ) : ?> Website www.nuvasive.com. 3. Spine 2020;45(14):944-51. PLoS ONE 2011;6(10):1-8. List of devices made by the manufacturer NUVASIVE, INC. The site is secure. NuVasives scale and global commercial channels will greatly accelerate the ability to bring the Simplify Disc to more surgeons and patients around the world.. ET / 1:30 p.m. PT to discuss these results. NuVasive provides patient support and surgeon education. Alignment Matters . The company offers implants, fixation products, intraoperative monitoring (IOM) services, disposables, and biologics for use in spinal surgery. The materials on this website are for your general educational information only. An official website of the United States government, : $1,299.99. 1. Information you read on this website cannot replace the relationship that you have with your healthcare professional. Robert Eastlack and Gregory Mundis. Telephone 1 858 9091800. NuVasive Launches Modulus ALIF 3D-Printed Porous Titanium Implant for Weve partnered with the worlds leading surgeons to advance cervical surgery and deliver a comprehensive, procedurally integrated portfolio for anterior and posterior cervical proceduresC360. For care of patients who currently have one of these devices and weigh less than 50 pounds and/or have more than two devices implanted, the health care team should assess treatment progression and consider removal of nails promptly at the end of treatment. WestCMR does not provide advice, training, or clinical support. San Diego, California 92121 Re: K210214 Trade/Device Name: NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX NuVasive provides patient support and surgeon education. NuVasive plans to announce tomorrow its financial results for the fourth quarter and full year ended Dec. 31, 2020. If so, do not buy this item unless you are an authorized purchaser. We do not practice medicine or provide medical services or advice as a part of this website. 4. Investor Conference Call NuVasive is the fastest growing, full-line spine company. Osteoinduction of human mesenchymal stem cells by bioactive composite scaffolds without supplemental osteogenic growth factors. Conmed Linvatec E9010 CoolFlex E9000 High Speed Drill. Indications For Use NUWAVE is a germicide intended to disinfect non-critical medical devices and equipment surfaces including CPAP masks, tubing and water chambers. NuVasive has launched its Reline MAS Midline (RMM), the next evolution of its Reline system designed to provide procedural versatility in a compact midline construct. Philips L12-5 Linear Probe - 50mm Compact 256-Element Transducer ~ BRAND NEW ~. function gtag(){dataLayer.push(arguments);} 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. The Company will hold a conference call tomorrow, Feb. 25, 2021, at 4:30 p.m. combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531- 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. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. Transpsoas access 4. Biologics - NuVasive PDF NVM5 Computer-Assisted Rod Bending Journal of Neurosurgery Spine. 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. The acquisition of Simplify Medical adds the most clinically effective cTDR technology and further distinguishes NuVasive's cervical portfolio in the market. Potential Biocompatibility Concerns with NuVasive Specialized /PRNewswire/ -- NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive,. 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. The Companys less-invasive, procedurally integrated surgical solutions are designed to deliver reproducible and clinically proven outcomes. For the best experience on our site, be sure to turn on Javascript in your browser. You have not been assigned a username and password. See here for a complete list of exchanges and delays. 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. Ensure patients with a Precice device continue to receive appropriate follow-up monitoring. One position. var tpl_folder = "https://www.medicaldevices24.com/public/tpl"; D. Device Description 50 - 99 pieces - 8,75. All quotes delayed a minimum of 15 minutes. Expected delivery: 3 weeks. Advisors Excluding VAT and shipping. Three New Biologic Products for Spine Surgery The sale of this item may be subject to regulation by the U.S. Food and Drug Administration and state and local regulatory agencies. Prices (minimum order quantity 144 pieces)144 pieces - 2,75288 pieces - 2,50more than 500 pieces - pleasecontact usfor a new quote. There are no new recommendations regarding the stainless steel-based Precice devices since the July 2021 letter to health care providers. The Reline portfolio represents the evolution of posterior fixation technology, providing integrated Open and MAS procedural solutions. NUVASIVE USA: 'NNUVASIVE' NuVasive, Inc. ~L ~ o 7475 Lusk Blvd. 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. This reflects the technologys favorable growth and margin profile, combined with NuVasives substantial commercial capability and C360 portfolio integration. All products sold by WestCMR are in-date. NuVasive, 8050015, NuVasive NVM5 EMG Needle Module - eSutures STRYKER 502-427-030 VIDEO ARTHROSCOPE, 4MM 30 DEG. Read the press release The Attrax ceramic surface has unique microstructure and microporosity that are optimized for bone formation. PDF Document Title: Visual and Cosmetic Standards for Manufacturing Expected delivery: 3 weeks. ALIF - NuVasive westcmrglobal.com |geosurgical.com |wareconsultingllc.com, West Coast Medical Resources | Serving the surgical community since 1997. The following important factors, among others, could cause actual results to differ materially from those set forth in the forward-looking statements: the loss of key employees; the risk that the businesses will not be integrated successfully; unexpected variations in market growth and demand for the combined companys products and technologies; and the risk that benefits from the acquisition may not be fully realized or may take longer to realize than expected. Copyright 2022 Oisto. Prices excluding VAT and shipping. NuVasive is committed to a global approach for assessing, preserving, and restoring spinal alignment in an effort to promote surgical efficiencies, lasting patient outcomes, and improved quality of life. or more while undergoing treatment, and. 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. Bone Preparation & Cement Application Kits, Balloon Dilatation Catheters Insertion Kits, Skip to the beginning of the images gallery. Reimagine cervical spine surgery. Based on review of publicly available materials at the time of this release. In this video, they review the findings around improved patient outcomes and reduced economic burden when using these products together. As of date of publication, March 2017; 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. Propel DBM Fibers and Propel DBM Sponge are 100% bone and are intended for homologous use in the repair, replacement, or reconstruction of skeletal defects. For the best experience on our site, be sure to turn on Javascript in your browser. NuVasive and Globus Medical are combining to bring together two well-regarded technology companies in the musculoskeletal industry. NuVasive offers solutions to alleviate patient symptoms. If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE). Learn how the use of Attrax Putty in Modulus XLIF cages resulted in a 97.8% rate of bone bridging5 from Drs. Can a bioactive interbody device reduce the cost burden of achieving lateral lumbar fusion? Based in San Diego, NuVasive acquired Simplify Medical earlier this year with a $150 million upfront payment to expand its cervical spine technology portfolio. Precice devices are implants intended for patients 18 years and over, to lengthen the limb, shorten or compress the limb, or transport segments of long bones.
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