%PDF-1.5 % Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. NuVasive offers solutions to alleviate patient symptoms. Lehr MA, Oner CF, Delawi D, et al. Prices(minimum order quantity 25 pieces)25 - 50 pieces - 13.6551 - 100 pieces - 11,25more than 100 pieces- pleasecontact usfor a new quote. PDF NuVasive, Incorporated Jessica LeBlanc Senior Specialist, Regulatory The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with NuVasive Precice devices. The NuVasive TLIF philosophy, coupled with its comprehensive portfolio, provides open and MAS procedural systems that include the requisite tools surgeons need to plan surgery, access affected levels, restore alignment and disc height, provide optimized fixation, and deliver graft material. Osteocel is human tissue donated specifically for human clinical use. NuVasive BASE Interfixated Titanium System cleared in 510(k) K170592. Expected delivery: 2 weeks. COCCYX ZONE OF SPINE FOR. PDF Document Title: Visual and Cosmetic Standards for Manufacturing multi-level pathologies. PDF eXtreme - SMISS The Companys less-invasive, procedurally integrated surgical solutions are designed to deliver reproducible and clinically proven outcomes. You don't have to face this journey alone. Thu, October 4th, 2018. Prices excluding VAT and shipping. Attrax Putty is now the first and only synthetic biologic to receive 510(k) clearance for use with thoracolumbar interbody systems. Prices (minimum order quantity 144 pieces)144 pieces - 2,75288 pieces - 2,50more than 500 pieces - pleasecontact usfor a new quote. RCCmyf(&3Tn@}M S,3c6qr|b2#JQ|%^@ZQTK,1gCTS pD"d(GR ~h'! Innovation in Musculoskeletal Solutions | Globus Medical At this time, the FDA is not aware of reports of adverse events related to biocompatibility issues with titanium-based Precice devices. All quotes delayed a minimum of 15 minutes. The purpose of this document is to define the standardization of cosmetic and visual acceptance criteria for NuVasive products upon receipt from the manufacturer. 2020 - Investor Conference Call PCF - NuVasive - PDF Catalogs | Technical Documentation or more while undergoing treatment, and. Three New Biologic Products for Spine Surgery. The disc is comprised of two parts, a tough and fibrous outer layer (annulus fibrosis), and a soft, gelatinous center (nucleus pulposus). hbbd``b`I3@R $eL :X] BDLv ^e a$@@ He`bd^d100H xl We do not practice medicine or provide medical services or advice as a part of this website. Our Standards: The Thomson Reuters Trust Principles. Propel DBM Putty Plus and Gel Plus contain added cancellous chips and serve as a bone graft extender (extremities, posterolateral spine, pelvis) and bone void filler of the extremities and pelvis. NuVasive is developing the operating room of the future. 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 you have questions about this letter, contact the Division of Industry and Consumer Education (DICE). Neurocare Products. 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. PDF User Manual - Nuwave Cpap Peer-to-peer discussion between Drs. Please close the page and access the Company Store via Okta. /PRNewswire/ -- NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive,. 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. Excluding VAT and shipping. Bone grafting is a surgical technique that involves implanting a bone substitute or extender to help the body achieve spinal fusion. Telephone 1 858 9091800. NuVasive provides patient support and surgeon education. NuVasive, Incorporated Jessica LeBlanc Senior Specialist, Regulatory Affairs 7475 Lusk Boulevard San Diego, California 92121 Re: K191974 Trade/Device Name: NuVasive AttraX Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV The SRS-Schwab adult spinal deformity classification: Do not implant in patients under 18 years of age.
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