NuVasive Inc

FDA Regulatory Profile

Summary

Total Recalls
36
510(k) Clearances
92
Inspections
22
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0738-2023Class IIX-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixatiNovember 10, 2022
Z-1052-2023Class IIINuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BJuly 19, 2022
Z-1453-2022Class IIDescription/Part: Simplify Disc Size 1, Ht 5/SM-5; Simplify Disc Size 1, Ht 6/SM-6; Simplify DisJune 20, 2022
Z-2684-2020Class IINuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 00887517206633 - Product UJune 10, 2020
Z-1898-2020Class IINUVASIVE MAGEC 2 Rod X.X mm XX mm, REF MC2-XXXXS LOT 0000000 AAA - Product Usage: comprised of a sFebruary 13, 2020
Z-0370-2013Class II5.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIJanuary 5, 2009
Z-0362-2013Class II7.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIJanuary 5, 2009
Z-0363-2013Class II7.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIJanuary 5, 2009
Z-0372-2013Class II5.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIJanuary 5, 2009
Z-0355-2013Class II6.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIJanuary 5, 2009
Z-0352-2013Class II5.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIJanuary 5, 2009
Z-0364-2013Class II7.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIJanuary 5, 2009
Z-0366-2013Class II7.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIJanuary 5, 2009
Z-0357-2013Class II6.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIJanuary 5, 2009
Z-0377-2013Class II7.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIJanuary 5, 2009
Z-0359-2013Class II6.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIJanuary 5, 2009
Z-0375-2013Class II6.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIJanuary 5, 2009
Z-0378-2013Class II7.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIJanuary 5, 2009
Z-0374-2013Class II6.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIJanuary 5, 2009
Z-0367-2013Class IIScrew Tulip , 5.5mm Rod Subsequent Codes: KWP, KWQ, MNH, MNIJanuary 5, 2009

Recent 510(k) Clearances

K-NumberDeviceDate
K233706Bendini Cloud ApplicationAugust 2, 2024
K240507NuVasive AttraX ScaffoldMarch 20, 2024
K223731NuVasive Modulus-C Interbody SystemJanuary 12, 2023
K211757Simplify DiscAugust 20, 2021
K173117NuVasive® VersaTie™ SystemDecember 7, 2017
K141665NuVasive CoRoent SystemMarch 13, 2015
K142205NuVasive X-CORE(R) Expandable VBR SystemFebruary 20, 2015
K141968NUVASIVE NVM5 SYSTEMNovember 14, 2014
K140319COROENT TI-C SYSTEMOctober 9, 2014
K140162AP EXPANDABLE XLIF SYSTEMJuly 2, 2014
K140003COROENT SMALL INTERBODY SYSTEMApril 3, 2014
K133052AFFIX(R) NEXT GEN SPINOUS PROCESS PLATE SYSTEMDecember 20, 2013
K131025ARCHON ANTERIOR CERVICAL PLATE SYSTEMNovember 27, 2013
K132014GSB GLOBAL SPINAL BALANCE SYSTEMOctober 31, 2013
K131723COROENT SINGLE TAB SYSTEMSeptember 20, 2013
K130868NUVASIVE DECADE LATERAL PLATE SYSTEMAugust 29, 2013
K131238AFFIX SPINOUS PROCESS PLATE SYSTEMJuly 2, 2013
K123307NUVASIVE NVM5 SYSTEMApril 23, 2013
K123045BRIGADE STANDALONE SYSTEMApril 16, 2013
K122081NUVASIVE LONG LATERAL SPINAL SYSTEMFebruary 1, 2013