# Pro Surgical, Inc.

- Location (FDA's records): Carlsbad, CA
- FDA decisions: 3 (2024–2025): 3 510(k) clearances
- Product codes: OVD (2), OVE (1)
- 510(k) review time since 2016: median 89 days, against 100 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 11 (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
- Astura Medical: 3 (https://510kreport.com/company/astura-medical)
- Nu Vasive, Incorporated: 1 (https://510kreport.com/company/nu-vasive)
- Osseus Fusion Systems, LLC: 1 (https://510kreport.com/company/osseus-fusion-systems)
- Spinal Elements, Inc.: 1 (https://510kreport.com/company/spinal-elements)
- Alphatec Spine, Inc.: 1 (https://510kreport.com/company/alphatec-spine)
- SeaSpine Orthopedics Corporation: 1 (https://510kreport.com/company/seaspine-orthopedics)
- Globus Medical, Inc.: 1 (https://510kreport.com/company/globus-medical)

## Its most-cited devices
- K240126: ProAM ALIF System (2024), cited by 2

## Recent decisions
- K251644: ProAM ALIF System (Jun 24, 2025)
- K242517: ProAM ACDF System (Nov 20, 2024)
- K240126: ProAM ALIF System (May 3, 2024)

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