# Foundation Surgical Group, Inc.

- Location (FDA's records): Scottsdale, AZ
- FDA decisions: 5 (2024–2026): 5 510(k) clearances
- Names in FDA's records: Foundation Surgical Group, Inc. (3); Foundation Surgical Group (2)
- Product codes: MQP (2), OVD (2), OLO (1)
- 510(k) review time since 2016: median 104 days, against 109 for FDA's reviews in the same codes and years (4 of 5 faster)
- Predicates its devices cite: 13 (2 its own); citations of its devices by later devices: 2 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medtronic Sofamor Danek USA, Inc.: 2 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Blackstone Medical, Inc.: 1 (https://510kreport.com/company/blackstone-medical)
- Stryker Spine: 1 (https://510kreport.com/company/stryker-spine)
- Nexxt Spine, LLC: 1 (https://510kreport.com/company/nexxt-spine)
- Astura Medical: 1 (https://510kreport.com/company/astura-medical)
- Precision Spine, Inc.: 1 (https://510kreport.com/company/precision-spine)
- Corelink, LLC: 1 (https://510kreport.com/company/corelink)
- Nu Vasive, Incorporated: 1 (https://510kreport.com/company/nu-vasive)

## Its most-cited devices
- K241468: Vertiwedge® Intraosseous System (2024), cited by 1
- K241487: Interwedge® Standalone Lateral (2024), cited by 1

## Recent decisions
- K261809: Interwedge® Standalone Lateral (Jul 31, 2026)
- K261810: Vertiwedge® Intraosseous System (Jul 31, 2026)
- K260011: Foundation Surgical Navigated Lateral Disc Prep Instruments (Apr 16, 2026)
- K241468: Vertiwedge® Intraosseous System (Nov 7, 2024)
- K241487: Interwedge® Standalone Lateral (Oct 2, 2024)

Source page: https://510kreport.com/company/foundation-surgical-group