# Nuvasive, Inc.

- Location (FDA's records): San Diego, CA
- FDA decisions: 94 (1999–2024): 92 510(k) clearances and 2 original PMA approvals
- Names in FDA's records: Nuvasive, Inc. (93); Nuvasive (1)
- Product codes: KWQ (21), NKB (9), ETN (6), MQP (6), GWF (5), MAX (5), MNH (4), OVD (4), MRW (4), OLO (3), ODP (3), MJO (2)
- 510(k) review time since 2016: median 50 days, against 84 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 155 (61 its own); citations of its devices by later devices: 355 (61 its own)
- Recalls linked to its devices: 34 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Nu Vasive, Incorporated: 15 (https://510kreport.com/company/nu-vasive)
- Synthes Spine: 6 (https://510kreport.com/company/synthes-spine)
- Surgicraft, Ltd.: 5 (https://510kreport.com/company/surgicraft)
- Axon Systems, Inc.: 4 (https://510kreport.com/company/axon-systems)
- Globus Medical, Inc.: 4 (https://510kreport.com/company/globus-medical)
- Rhythmlink International, LLC: 4 (https://510kreport.com/company/rhythmlink-international)
- Digitimer, Ltd.: 3 (https://510kreport.com/company/digitimer)
- Depuyacromed: 3 (https://510kreport.com/company/depuyacromed)

## Firms that cite its devices most
- Nu Vasive, Incorporated: 121 (https://510kreport.com/company/nu-vasive)
- Globus Medical, Inc.: 9 (https://510kreport.com/company/globus-medical)
- Life Spine, Inc.: 6 (https://510kreport.com/company/life-spine)
- Reliance Medical Systems, LLC: 6 (https://510kreport.com/company/reliance-medical-systems)
- Spineart: 5 (https://510kreport.com/company/spineart)
- Pioneer Surgical Technology: 5 (https://510kreport.com/company/pioneer-surgical-technology)
- K2m, Inc.: 5 (https://510kreport.com/company/k2m)
- Lanx, Inc.: 4 (https://510kreport.com/company/lanx)

## Its most-cited devices
- K071795: Nuvasive Coroent System (2007), cited by 42
- K081611: Nuvasive Coroent System (2008), cited by 18
- K141665: NuVasive CoRoent System (2015), cited by 18
- K073278: Spinous Process Plate System (2008), cited by 17
- K123045: Brigade Standalone System (2013), cited by 17
- K120918: Nuvasive Coroent Titanium System (2012), cited by 12

## Recent decisions
- K233706: Bendini Cloud Application (Aug 2, 2024)
- K240507: NuVasive AttraX Scaffold (Mar 20, 2024)
- K223731: NuVasive Modulus-C Interbody System (Jan 12, 2023)
- K211757: Simplify Disc (Aug 20, 2021)
- P200022: Simplify® Cervical Artificial Disc (Sep 18, 2020)
- K173117: NuVasive® VersaTie™ System (Dec 7, 2017)
- K141665: NuVasive CoRoent System (Mar 13, 2015)
- K142205: NuVasive X-CORE (R) Expandable VBR System (Feb 20, 2015)

Source page: https://510kreport.com/company/nuvasive