# Biogennix, LLC

- Location (FDA's records): Irvine, CA
- FDA decisions: 9 (2010–2024): 9 510(k) clearances
- Names in FDA's records: Biogennix, LLC (8); Biogennix (1)
- Product codes: MQV (7), OVD (1), MAX (1)
- 510(k) review time since 2016: median 104 days, against 114 for FDA's reviews in the same codes and years (2 of 5 faster)
- Predicates its devices cite: 14 (7 its own); citations of its devices by later devices: 7 (7 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
- Genesys Spine: 2 (https://510kreport.com/company/genesys-spine)
- K2m, Inc.: 1 (https://510kreport.com/company/k2m)
- Synthes Spine: 1 (https://510kreport.com/company/synthes-spine)
- Interpore Cross Intl.: 1 (https://510kreport.com/company/interpore-cross-intl)
- Novabone Products, LLC: 1 (https://510kreport.com/company/novabone-products)
- Apatech, Ltd.: 1 (https://510kreport.com/company/apatech)

## Its most-cited devices
- K093342: Biogennix RPC (2010), cited by 2
- K142828: osteoSPAN Morpheus (2015), cited by 2
- K132377: Osteospan Morpheus (2014), cited by 2
- K141798: Sypher Spacer System (2015), cited by 1

## Recent decisions
- K240621: Morpheus® Moldable; Agilon® Moldable (Apr 30, 2024)
- K193487: Agilon Strip (Mar 30, 2020)
- K193168: Agilon Moldable (Feb 13, 2020)
- K190371: Morpheus-C (Aug 9, 2019)
- K181337: Sypher Spacer System (Sep 18, 2018)
- K141798: Sypher Spacer System (Feb 19, 2015)
- K142828: osteoSPAN Morpheus (Jan 15, 2015)
- K132377: Osteospan Morpheus (May 20, 2014)

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