# Spine Wave, Inc.

- Location (FDA's records): Shelton, CT
- FDA decisions: 59 (2004–2026): 59 510(k) clearances
- Product codes: MAX (14), MNI (11), MQP (10), NKB (7), OLO (3), NKG (3), MNH (3), OVE (2), OVD (1), HRS (1), MRW (1), NDN (1)
- 510(k) review time since 2016: median 82 days, against 95 for FDA's reviews in the same codes and years (14 of 23 faster)
- Predicates its devices cite: 142 (76 its own); citations of its devices by later devices: 89 (76 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
- Globus Medical, Inc.: 10 (https://510kreport.com/company/globus-medical)
- Depuy Spine, Inc.: 4 (https://510kreport.com/company/depuy-spine)
- X-Spine Systems, Inc.: 3 (https://510kreport.com/company/x-spine-systems)
- Medtronic Sofamor Danek: 3 (https://510kreport.com/company/medtronic-sofamor-danek)
- Medtronic Sofamor Danek USA, Inc.: 2 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Nuvasive, Inc.: 2 (https://510kreport.com/company/nuvasive)
- Ldr Spine USA: 2 (https://510kreport.com/company/ldr-spine-usa)
- Biomet Spine: 2 (https://510kreport.com/company/biomet-spine)

## Firms that cite its devices most
- Nu Vasive, Incorporated: 3 (https://510kreport.com/company/nu-vasive)
- Orthovita, Inc.: 2 (https://510kreport.com/company/orthovita)
- Captiva Spine, Inc.: 1 (https://510kreport.com/company/captiva-spine)
- Creaspine: 1 (https://510kreport.com/company/creaspine)
- Premia Spine, Ltd.: 1 (https://510kreport.com/company/premia-spine)
- Benvenue Medical, Inc.: 1 (https://510kreport.com/company/benvenue-medical)
- Alphatec Spine, Inc.: 1 (https://510kreport.com/company/alphatec-spine)
- Ouroboros Medical: 1 (https://510kreport.com/company/ouroboros-medical)

## Its most-cited devices
- K083353: Capsure (R) PS System (2008), cited by 5
- K052670: Staxx XD System (2006), cited by 5
- K081228: Capsure PS (R) Spine System (2008), cited by 5
- K123461: Staxx (R) IB System (2013), cited by 4
- K090315: Staxx XD System (2009), cited by 4
- K100605: Mis System (2010), cited by 4

## Recent decisions
- K260286: Dynamo™ Spinal Cement; Salvo® Spine System (Jun 15, 2026)
- K261159: Exceed® Biplanar Expandable Interbody System (May 29, 2026)
- K243816: Testa TP Pivoting Spacer System (Jun 27, 2025)
- K251131: Annex® 2 Adjacent Level System (Jun 6, 2025)
- K243514: Salvo® Robotic Navigation Instruments (Apr 3, 2025)
- K240685: Salvo® Spine System (May 6, 2024)
- K231275: Exceed™ Biplanar Expandable Interbody System (Jul 25, 2023)
- K222362: Salvo® Spine System (Aug 29, 2022)

Source page: https://510kreport.com/company/spine-wave