# SurGenTec, LLC

- Location (FDA's records): Boca Raton, FL
- FDA decisions: 33 (2017–2026): 33 510(k) clearances
- Names in FDA's records: SurGenTec, LLC (30); Surgentec (3)
- Product codes: OUR (8), MRW (6), FMF (6), MQV (5), OLO (3), KNW (2), PDQ (1), GZT (1), HRX (1)
- 510(k) review time since 2016: median 93 days, against 103 for FDA's reviews in the same codes and years (17 of 32 faster)
- Predicates its devices cite: 59 (30 its own); citations of its devices by later devices: 38 (30 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
- Providence Medical Technology, Inc.: 4 (https://510kreport.com/company/providence-medical-technology)
- Novabone Products, LLC: 4 (https://510kreport.com/company/novabone-products)
- Medtronic Sofamor Danek USA, Inc.: 3 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Medtronic Sofamor Danek: 3 (https://510kreport.com/company/medtronic-sofamor-danek)
- Orthovita, Inc.: 2 (https://510kreport.com/company/orthovita)
- Ranfac, Corp.: 2 (https://510kreport.com/company/ranfac)
- Globus Medical, Inc.: 1 (https://510kreport.com/company/globus-medical)
- Spinefrontier, Inc.: 1 (https://510kreport.com/company/spinefrontier)

## Firms that cite its devices most
- Globus Medical, Inc.: 2 (https://510kreport.com/company/globus-medical)
- Md3, LLC: 1 (https://510kreport.com/company/md3)
- Sc Medica: 1 (https://510kreport.com/company/sc-medica)
- Orthofix, Inc.: 1 (https://510kreport.com/company/orthofix)
- Lesspine Innovations: 1 (https://510kreport.com/company/lesspine-innovations)
- Lifenet Health: 1 (https://510kreport.com/company/lifenet-health)
- Aurora Spine, Inc.: 1 (https://510kreport.com/company/aurora-spine)

## Its most-cited devices
- K170675: Graftgun Universal Graft Delivery System (2017), cited by 7
- K211855: Ion Facet Screw System (2022), cited by 6
- K180937: Graftgun Universal Graft Delivery System (2018), cited by 4
- K230446: TiLink-L SI Joint Fusion System (2023), cited by 2
- K240720: TiLink-P SI Joint Fusion System (2024), cited by 2
- K240086: Ion 3D (2024), cited by 2

## Recent decisions
- K263208: Vantage Lumbar Decompression Kit (Oct 14, 2026)
- K252995: Durashield Device Kit (Sep 17, 2026)
- K262581: GraftGun Universal Graft Delivery System (GDS®) (Aug 26, 2026)
- K261381: TiLink-L™ SI Joint Fusion System (Aug 24, 2026)
- K262121: Ion-L Navigated Instruments (Jul 24, 2026)
- K261209: Ion-L (Jun 11, 2026)
- K260329: Ion-C Navigation Instruments (May 22, 2026)
- K253604: TiLink-L Navigation Instruments (Mar 20, 2026)

Source page: https://510kreport.com/company/surgentec