# Sapphire Medical Group

- Location (FDA's records): Dana Point, CA
- FDA decisions: 5 (2012–2024): 5 510(k) clearances
- Names in FDA's records: Sapphire Medical Group (4); Sapphire Medical Group, Inc. (1)
- Product codes: ODP (3), KWQ (1), MAX (1)
- 510(k) review time since 2016: median 78 days, against 87 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 5 (1 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
- L&K BIOMED Co., Ltd.: 2 (https://510kreport.com/company/l-k-biomed)
- Spineworks, LLC: 1 (https://510kreport.com/company/spineworks)

## Firms that cite its devices most
- Cogent Spine, LLC: 1 (https://510kreport.com/company/cogent-spine)
- Innovasis, Inc.: 1 (https://510kreport.com/company/innovasis)
- Spineworks, LLC: 1 (https://510kreport.com/company/spineworks)
- Infront Medical, LLC: 1 (https://510kreport.com/company/infront-medical)

## Its most-cited devices
- K121693: A-Wedge Anterior Interbody System (a-Wedge Ais) (2012), cited by 3
- K192316: Matrix HA PEEK Cervical Implant System (2019), cited by 1
- K172674: Sapphire Cervical Implant System (2017), cited by 1

## Recent decisions
- K232619: MATRIX HA PEEK Cervical IBF System (Mar 19, 2024)
- K192316: Matrix HA PEEK Cervical Implant System (Oct 17, 2019)
- K183073: SMG Anterior Cervical Plate System (Feb 11, 2019)
- K172674: Sapphire Cervical Implant System (Nov 2, 2017)
- K121693: A-Wedge Anterior Interbody System (a-Wedge Ais) (Dec 27, 2012)

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