# Nu Vasive, Incorporated

- Location (FDA's records): San Diego, CA
- FDA decisions: 112 (2012–2023): 112 510(k) clearances
- Product codes: MAX (34), NKB (10), OVD (10), ODP (8), KWQ (7), NKG (6), MQP (5), PDQ (5), OLO (5), OVE (4), MQV (2), PLR (2)
- 510(k) review time since 2016: median 91 days, against 106 for FDA's reviews in the same codes and years (44 of 75 faster)
- Predicates its devices cite: 401 (188 its own); citations of its devices by later devices: 375 (188 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Nuvasive, Inc.: 121 (https://510kreport.com/company/nuvasive)
- Medtronic Sofamor Danek USA, Inc.: 10 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Globus Medical, Inc.: 8 (https://510kreport.com/company/globus-medical)
- Medtronic Sofamor Danek: 5 (https://510kreport.com/company/medtronic-sofamor-danek)
- Progentix Orthobiology BV: 4 (https://510kreport.com/company/progentix-orthobiology)
- Alphatec Spine, Inc.: 4 (https://510kreport.com/company/alphatec-spine)
- Osteotech, Inc.: 3 (https://510kreport.com/company/osteotech)
- Vertera, Inc.: 3 (https://510kreport.com/company/vertera)

## Firms that cite its devices most
- Globus Medical, Inc.: 25 (https://510kreport.com/company/globus-medical)
- Alphatec Spine, Inc.: 22 (https://510kreport.com/company/alphatec-spine)
- Nuvasive, Inc.: 15 (https://510kreport.com/company/nuvasive)
- SeaSpine Orthopedics Corporation: 7 (https://510kreport.com/company/seaspine-orthopedics)
- Kuros Biosciences B.V: 6 (https://510kreport.com/company/kuros-biosciences-b-v)
- Life Spine, Inc.: 6 (https://510kreport.com/company/life-spine)
- Medos International SARL: 5 (https://510kreport.com/company/medos-international)
- Astura Medical: 5 (https://510kreport.com/company/astura-medical)

## Its most-cited devices
- K203714: NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, NuVasive Attrax Putty (2021), cited by 31
- K161230: NuVasive Lumbar Interbody Implants (2016), cited by 16
- K163491: NuVasive CoRoent Small Interbody System (2017), cited by 13
- K170962: NuVasive® CoRoent® Thoracolumbar System (2017), cited by 12
- K163230: NuVasive Modulus XLIF Interbody System (2017), cited by 11
- K170592: NuVasive BASE Interfixated Titanium System (2017), cited by 10

## Recent decisions
- K231735: NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent Small Interlock System; NuVasive CoRoent Small Interlock II System; NuVasive CoRoent Small Ti-C System; NuVasive Cohere Cervical Interbody System (Jul 11, 2023)
- K230894: NuVasive Modulus ALIF System (Jun 16, 2023)
- K230989: Rod Registration Frame (May 5, 2023)
- K223181: NuVasive Reline System (Jan 11, 2023)
- K221751: NuVasive Cohere ALIF System Intervertebral Body Fusion Device (Oct 21, 2022)
- K221388: NuVasive Reline Cervical System (Sep 9, 2022)
- K220478: NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody System (Jun 21, 2022)
- K213654: NuVasive Reline Cervical System (Feb 23, 2022)

Source page: https://510kreport.com/company/nu-vasive