NuVasive Inc Company Profile - GlobalData Before sharing sensitive information, make sure you're on a federal government site. nuvasive product catalog pdf 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. For the best experience on our site, be sure to turn on Javascript in your browser. 4. NuVasive Launches Modulus ALIF 3D-Printed Porous Titanium Implant for Height 25cm, diameter 7cm - Volume: 500 ml. PCF - NuVasive - PDF Catalogs | Technical Documentation WestCMR does not represent or claim any relationship to the respective companies or their equipment or products, names are used for reference only. The acquisition of Simplify Medical adds the most clinically effective cTDR technology and further distinguishes NuVasives cervical portfolio in the market. 2020 - Anterior lumbar interbody fusion (ALIF) is a surgical procedure used to treat problems such as disc degeneration, spinal instability, and deformities of the spine. A live webcast of the conference call will be available online from the Investor Relations page of the Companys website atwww.nuvasive.com. 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. You don't have to face this journey alone. 2.0 Scope NuVasive introduces new Reline 3D posterior fixation system The NuVasive CPD program focuses on surgeon development through the design and delivery of innovative clinical education programs. Copyright 2022 Oisto. San Diego, CA 92121 PCM THE CERVICAL DISC SYSTEM INSTRUCTIONS FOR USE Rx Only GRAPHICAL SYMBOLS Read Instructions Before Use Single Use Only Catalog Number Lot Number STLE RSterile by Irradiation Non-Sterile, Sterilize by Steam before Use Manufacturer Use By HOW SUPPLIED Excluding VAT and shipping. 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. The Company expects the acquisition to accelerate net sales growth and be accretive to non-GAAP diluted earnings per share in 2022. PDF User Manual - Nuwave Cpap All quotes delayed a minimum of 15 minutes. Our combined innovative technologies will create differentiated, comprehensive procedural solutions to better support surgeons, healthcare providers and patients. The .gov means its official.Federal government websites often end in .gov or .mil. 1 Terran J, Schwab F, Shaffrey CI, et al. Expected delivery: 3 weeks. Make sure cookies are enabled in your browser. hbbd``b`I3@R $eL :X] BDLv ^e a$@@ He`bd^d100H xl 888 0 obj <>stream 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 Our Standards: The Thomson Reuters Trust Principles. 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. As the innovation leader in spine, our goal is to provide you with comprehensive procedural solutions and enabling technology to change patient lives. The materials on this website are for your general educational information only. PLoS ONE 2011;6(10):1-8. Letters to Health Care Providers, Recalls, Market Withdrawals and Safety Alerts, UPDATE: Potential Biocompatibility Concerns with NuVasive Specialized Orthopedics Precice Devices - Letter to Health Care Providers, MedWatch, the FDA Safety Information and Adverse Event Reporting program, July 2021 letter to health care providers, Medical Device Reporting (MDR) regulations, FDA's user facility reporting requirements, Division of Industry and Consumer Education (DICE), Potential Biocompatibility Concerns with NuVasive Specialized Orthopedics Precice Devices - Letter to Health Care Providers, Precice Intra-medullary Limb Lengthening Device. function gtag(){dataLayer.push(arguments);} %PDF-1.5 % NuVasive and Globus Medical are combining to bring together two well-regarded technology companies in the musculoskeletal industry. Alignment Matters . Headquarters United States of America. Three New Biologic Products for Spine Surgery. In this list are all medical devices registered by the ministry of health that are produced by the manufacturer NUVASIVE, INC. Name: NUVASIVE, INC. 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. gtag('js', new Date()); 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. Attrax Putty is now the first and only synthetic biologic to receive 510(k) clearance for use with thoracolumbar interbody systems. COCCYX ZONE OF SPINE FOR. Unhappy? Bone grafting is a surgical technique that involves implanting a bone substitute or extender to help the body achieve spinal fusion. Expected delivery: 3 weeks. Browse an unrivalled portfolio of real-time and historical market data and insights from worldwide sources and experts. Becoming the number one partner in pediatrics. Open the catalog to page 2 What is causing my pain? NuVasive offers solutions to alleviate patient symptoms. NuVasive is now able to address all key segments of the cervical spine by offering comprehensive, procedurally integrated solutions across anterior cervical discectomy and fusion (ACDF), posterior cervical fusion (PCF), and cTDR procedures. if( $robots ) : ?> 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.