# Blustone Synergy, LLC

- Location (FDA's records): Pueblo, CO
- FDA decisions: 3 (2017–2021): 3 510(k) clearances
- Names in FDA's records: Blustone Synergy, LLC (2); Blustone Synergy (1)
- Product codes: OVE (1), ODP (1), MQP (1)
- 510(k) review time since 2016: median 141 days, against 97 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 10 (0 its own); citations of its devices by later devices: 0 (0 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
- Globus Medical, Inc.: 3 (https://510kreport.com/company/globus-medical)
- Bluestone Synergy: 2 (https://510kreport.com/company/bluestone-synergy)
- X-Spine Systems, Inc.: 2 (https://510kreport.com/company/x-spine-systems)
- Amendia, Inc.: 1 (https://510kreport.com/company/amendia)
- Astura Medical: 1 (https://510kreport.com/company/astura-medical)
- Eminent Spine: 1 (https://510kreport.com/company/eminent-spine)

## Recent decisions
- K210382: Blustone Synergy Diamond SA Cervical System (Jul 23, 2021)
- K203520: Blustone Synergy Interbody Fusion System (Apr 7, 2021)
- K172330: Blustone Synergy Silica System (Dec 21, 2017)

Source page: https://510kreport.com/company/blustone-synergy