# Axogen Corporation

- Location (FDA's records): Alachua, FL
- FDA decisions: 3 (2017–2023): 3 510(k) clearances
- Product codes: JXI (3)
- 510(k) review time since 2016: median 123 days, against 122 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 2 (1 its own); citations of its devices by later devices: 2 (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
- Cook Biotech, Inc.: 1 (https://510kreport.com/company/cook-biotech)

## Firms that cite its devices most
- Biocircuit Technologies, Inc.: 1 (https://510kreport.com/company/biocircuit-technologies)

## Its most-cited devices
- K223640: Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48) (2023), cited by 2

## Recent decisions
- K231708: Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48) (Oct 12, 2023)
- K223640: Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48) (Apr 7, 2023)
- K163446: AxoGen Nerve Cap (Aug 8, 2017)

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