# Synergy Biomedical

- Location (FDA's records): Collegeville, PA
- FDA decisions: 5 (2013–2024): 5 510(k) clearances
- Names in FDA's records: Synergy Biomedical (2); Synergy Biomedical, LLC (2); Synergy Biomedical, Inc. (1)
- Product codes: MQV (5)
- 510(k) review time since 2016: median 238 days, against 124 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 10 (4 its own); citations of its devices by later devices: 4 (4 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
- Novabone Products, LLC: 2 (https://510kreport.com/company/novabone-products)
- Nu Vasive, Incorporated: 1 (https://510kreport.com/company/nu-vasive)
- Depuy Spine, Inc.: 1 (https://510kreport.com/company/depuy-spine)
- Biomet Spine: 1 (https://510kreport.com/company/biomet-spine)
- Interpore Cross Intl.: 1 (https://510kreport.com/company/interpore-cross-intl)

## Its most-cited devices
- K122868: Biosphere Bioactive Bone Graft Putty (2013), cited by 3
- K140844: Biosphere Bioactive Bone Graft Putty, 2.5CC, 5CC, 10CC (2014), cited by 1

## Recent decisions
- K241167: BioSphere Putty; BioSphere MIS Putty (Dec 20, 2024)
- K173424: BioSphere Flex (Sep 12, 2018)
- K173301: BioSphere MIS Putty (BioSphere MIS) (Jan 19, 2018)
- K140844: Biosphere Bioactive Bone Graft Putty, 2.5CC, 5CC, 10CC (Jul 16, 2014)
- K122868: Biosphere Bioactive Bone Graft Putty (Apr 19, 2013)

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