Nuvasive, Inc.
Nuvasive, Inc. holds FDA 510(k) medical device clearances, first cleared 1999, most recent 2024, with 36 FDA device recalls on record.
Top product codes for Nuvasive, Inc.
FDA recalls by Nuvasive, Inc.
10 most recent of 36- Z-0738-2023 — X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixation.
- Z-1052-2023 — NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US
- Z-1453-2022 — Description/Part: Simplify Disc Size 1, Ht 5/SM-5; Simplify Disc Size 1, Ht 6/SM-6; Simplify Disc Size 2, Ht 4/MD-4; Simplify Disc Size 2, Ht 5/MD-5; Simplify Disc Size 2, Ht 5, 5/MD-5L; Simplify Disc Size 2, Ht 6/MD-6; Simplify Disc Size 2, Ht 6, 5/MD-6L; Simplify Disc Size 3, Ht 5/LG-5; Simplify Disc Size 3, Ht 5, 5/LG-5L; Simplify Disc Size 3, Ht 6/LG-6; Simplify Disc Size 3, Ht 6, 5/LG-6L
- Z-2684-2020 — Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 00887517206633 - Product Usage: is intended for intraoperative neurophysiologic monitoring during spinal surgery.
- Z-1898-2020 — NUVASIVE MAGEC 2 Rod X.X mm XX mm, REF MC2-XXXXS LOT 0000000 AAA - Product Usage: comprised of a sterile single-use spinal rod that is surgically implanted using appropriate NuVasive Reline, Reline Small Stature, and Armada fixation components (i.e. Pedicle screws, hooks and/or connectors, provided non-sterile, to be sterilized by the end user).
- Z-0359-2013 — 6.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Z-0355-2013 — 6.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Z-0357-2013 — 6.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Z-0351-2013 — 5.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Z-0375-2013 — 6.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Nuvasive, Inc.
- K240507 — NuVasive AttraX Scaffold
- K223731 — NuVasive Modulus-C Interbody System
- K211757 — Simplify Disc
- K173117 — NuVasive® VersaTie System
- K141665 — NuVasive CoRoent System
- K142205 — NuVasive X-CORE(R) Expandable VBR System
- K141968 — NUVASIVE NVM5 SYSTEM
- K140319 — COROENT TI-C SYSTEM
- K140162 — AP EXPANDABLE XLIF SYSTEM
- K140003 — COROENT SMALL INTERBODY SYSTEM
- K133052 — AFFIX(R) NEXT GEN SPINOUS PROCESS PLATE SYSTEM
- K131025 — ARCHON ANTERIOR CERVICAL PLATE SYSTEM
- K132014 — GSB GLOBAL SPINAL BALANCE SYSTEM
- K131723 — COROENT SINGLE TAB SYSTEM
- K130868 — NUVASIVE DECADE LATERAL PLATE SYSTEM
- K131238 — AFFIX SPINOUS PROCESS PLATE SYSTEM
- K123307 — NUVASIVE NVM5 SYSTEM
- K123045 — BRIGADE STANDALONE SYSTEM
- K122081 — NUVASIVE LONG LATERAL SPINAL SYSTEM
- K122742 — NUVASIVE BENDINI SPINAL ROD BENDING SYSTEM
- K121815 — NUVASIVE SAGE LATERAL PLATE SYSTEM
- K122352 — NUVASIVE PRECEPT SPINAL SYSTEM
- K121619 — NUVASIVE POLYAXIAL SPINAL SCREWS
- K121837 — NUVASIVE BRIGADE ANTERIOR PLATE SYSTEM
- K120918 — NUVASIVE COROENT TITANIUM SYSTEM
- K112717 — NUVASIVE NVJJB SYSTEM
- K112718 — NUVASIVE NVM5 SYSTEM
- K112561 — NUVASIVE COROENT NO-PROFILE SYSTEM
- K111811 — BENDINI(TM) SPINAL ROD BENDING SYSTEM
- K111597 — DISPOSABLE STIMULATING ELECTRODE
- K111866 — NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM
- K111410 — NUVASIVE LONG LATERAL SPINAL SYSTEM
- K103750 — NUVASIVE TRAVERSE PLATE SYSTEM
- K102547 — COROENT INTERLOCK SYSTEM
- K102514 — NUVASIVE SPHERX II -MAS DEFORMITY SPINAL SYSTEM
- K101284 — FACET SCREW SYSTEM
- K093319 — NUVASIVE VUEPOINT OCT SYSTEM
- K100043 — COROENT XLR STANDALONE SYSTEM
- K094054 — MODIFCATION TO: NUVASIVE NEUROVISION EMG ENDOTRACHEAL TUBE
- K093804 — NUVASIVE HELIX REVOLUTION ACP SYSTEM
- K091623 — LAMINOPLASTY FIXATION SYSTEM
- K092287 — NUVASIVE SPHERX II - PEDICLE SCREW SYSTEM
- K091502 — NUVASIVE SPHERX II SYSTEM
- K090981 — MODIFICATION TO: NUVASIVE SPHERX SYSTEM
- K090298 — NUVASIVE NEURO VISION SYSTEM
- K091071 — NUVASIVE LATERAL PLATE SYSTEM
- K090176 — NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM
- K083341 — NUVASIVE HELIX-T ACP SYSTEM
- K081377 — NUVASIVE SURGICAL MESH SYSTEM
- K083028 — MODIFICATION TO: NUVASIVE SPHERX II SYSTEM
- K082332 — NUVASIVE SPHERX SYSTEM
- K081611 — NUVASIVE COROENT SYSTEM
- K082070 — NUVASIVE LATERAL PLATE SYSTEM
- K073278 — SPINOUS PROCESS PLATE SYSTEM
- K073275 — NUVASIVE HELIX MINI ACP SYSTEM
- K071795 — NUVASIVE COROENT SYSTEM
- K072343 — NEUROVISION JJB SYSTEM
- K072339 — NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM
- K071329 — NUVASIVE HELIX ACP SYSTEM
- K071435 — NUVASIVE OCT SYSTEM
- K070148 — GRAFT CONTAINMENT DEVICE
- K070273 — MODIFICATION TO NUVASIVE LATERAL PLATE SYSTEM
- K062765 — MODIFICATION TO NUVASIVE NEUROVISION JJB SYSTEM
- K062590 — NUVASIVE ACP4 SYSTEM
- K062317 — MODIFICATION TO NUVASIVE SPHERX II SYSTEM
- K061789 — LATERAL PLATE SYSTEM
- K061778 — NUVASIVE SPHERX II SYSTEM
- K053215 — SURGICAL MESH SYSTEM
- K060225 — NUVASIVE SPHERX SYSTEM
- K053581 — NUVASIVE SMARTPLATE GRADIENT PLUS SYSTEM
- K052210 — NUVASIVE COROENT EXTENSURE SYSTEM
- K051718 — NUVASIVE NEUROVISION JJB SYSTEM
- K051384 — MODIFICATION TO: NUVASIVE NEUROVISION JJB SYSTEM
- K043405 — NUVASIVE COROENT SYSTEM
- K042034 — NUVASIVE MAXCESS LIGHT GUIDE
- K041447 — NUVASIVE ANTERIOR CERVICAL PLATE SYSTEM
- K033546 — NUVASIVE SPINAL SYSTEM
- K040543 — NUVASIVE NEUROVISION JJB SYSTEM
- K032476 — NUVASIVE MESH
- K032083 — NUVASIVE NEUROVISION JJB SYSTEM
- K032180 — NUVASIVE CEMENT RESTRICTOR
- K023319 — NUVASIVE MASH
- K020853 — NUVASIVE MESH
- K020411 — NUVASIVE TRIAD FACET SCREW SYSTEM
- K013257 — HEMI-ARC SURGICAL NAVIGATOR
- K013215 — MODIFIED INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM
- K002677 — NUVASIVE INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM
- K001323 — NUVASIVE PERCUTANEOUS TRANSFACET/INTRAPEDICULAR SCREW
- K994308 — NUVASIVE TOWNLEY FACET SCREW
- K990324 — NUVASIVE GUIDED SPINAL ARTHROSCOPY SYSTEM
- K992782 — NUVASIVE SPINAL ARTHROSCOPE, MODELS 0, 30 AND 70 DEGREES
Data sourced from openFDA. This site is unofficial and independent of the FDA.