510(k) K223640 ยท JXI Cuff, Nerve
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)
| Applicant | Axogen Corporation, Alachua FL, US |
| Decision | Substantially Equivalent, Apr 7, 2023 |
| Received | Dec 5, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223640
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.