Data / Medical devices / United States / Axogen Corporation - Tampa Heights
Axogen Corporation - Tampa Heights: FDA-registered device maker in Tampa, FL, United States, 2 510(k) clearances
Axogen Corporation - Tampa Heights is registered with the FDA (registration 3017860045) in Tampa, FL, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated October 12, 2023. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3017860045
- Address
- 111 W Oak Ave Suite 500, Tampa, FL, United States, 33602
- Owner or operator
- AxoGen Corporation (10031236)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- October 4, 2017
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cuff, Nerve | JXI | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 12, 2023 | 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) | JXI | Substantially Equivalent | Axogen Corporation | accessdata.fda.gov |
| August 8, 2017 | K163446 | AxoGen Nerve Cap | JXI | Substantially Equivalent | Axogen Corporation | accessdata.fda.gov |
Compare with other makers
Updated October 12, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.