# Degen Medical

- Location (FDA's records): Florence, SC
- FDA decisions: 18 (2015–2025): 18 510(k) clearances
- Names in FDA's records: Degen Medical (16); Degen Medical, Inc. (2)
- Product codes: MAX (6), NKB (3), KWQ (3), OLO (2), ODP (2), OVD (2)
- 510(k) review time since 2016: median 85 days, against 87 for FDA's reviews in the same codes and years (7 of 15 faster)
- Predicates its devices cite: 63 (18 its own); citations of its devices by later devices: 24 (18 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
- Synthes (Usa): 5 (https://510kreport.com/company/synthes-usa)
- Depuy, Inc.: 5 (https://510kreport.com/company/depuy)
- Globus Medical, Inc.: 4 (https://510kreport.com/company/globus-medical)
- Alphatec Spine, Inc.: 3 (https://510kreport.com/company/alphatec-spine)
- Medtronic Sofamor Danek USA, Inc.: 3 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Depuy Spine, Inc.: 3 (https://510kreport.com/company/depuy-spine)
- Depuyacromed: 3 (https://510kreport.com/company/depuyacromed)
- Osseus Fusion Systems, LLC: 2 (https://510kreport.com/company/osseus-fusion-systems)

## Firms that cite its devices most
- Curiteva, Inc.: 3 (https://510kreport.com/company/curiteva)
- SeaSpine Orthopedics Corporation: 1 (https://510kreport.com/company/seaspine-orthopedics)
- Alphatec Spine, Inc.: 1 (https://510kreport.com/company/alphatec-spine)
- Carlsmed, Inc.: 1 (https://510kreport.com/company/carlsmed)

## Its most-cited devices
- K151496: Latitude-C Cervical Interbody Spacer System (2015), cited by 5
- K150759: Hyper-C Anterior Cervical Plate System (2015), cited by 4
- K223418: DeGen Impulse AM™ System (2023), cited by 2
- K240326: Solar™ Lumbar Interbody Fusion System (2024), cited by 2
- K210090: Impulse AM Interbody Fusion System (2021), cited by 2
- K142531: F1-Modular Pedicle Screw System (2015), cited by 2

## Recent decisions
- K251829: DeGen Medical Patient Specific Implant (PSI) System (Dec 8, 2025)
- K252737: DeGen Medical Latitude-C AM Cervical Interbody Fusion System (Oct 10, 2025)
- K250667: DeGen Medical Patient Specific Implant (PSI) System (Apr 4, 2025)
- K241077: DeGen Medical Patient Specific Implant (PSI) System (Oct 29, 2024)
- K240326: Solar™ Lumbar Interbody Fusion System (Jul 29, 2024)
- K231199: Solar Lumbar Interbody Fusion System (Jun 16, 2023)
- K223418: DeGen Impulse AM™ System (Mar 17, 2023)
- K213918: DeGen Navigated Instrumentation (Feb 9, 2022)

Source page: https://510kreport.com/company/degen-medical