AxoGen Nerve Cap
FDA 510(k) K163446 · Axogen Corporation
510(k) numberK163446
Submission
- Device name
- AxoGen Nerve Cap
- Applicant
- Axogen Corporation
Alachua, FL, US - Received
- December 8, 2016
- Decision date
- August 8, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code JXI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260245 | SILKBridgeJXI · Traditional | KLISBio S.r.l. | 04/09/2026SE |
| K253363 | NeuroSpan BridgeJXI · Traditional | Auxilium Biotechnologies, Inc. | 01/17/2026SE |
| K251505 | VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)JXI · Traditional | Alafair Biosciences | 07/22/2025SE |
| K251175 | VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201)JXI · Traditional | Alafair Biosciences | 07/17/2025SE |
| K243889 | Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40…JXI · Traditional | Orthocell, Ltd. | 04/02/2025SE |
| K242113 | Nerve Wrap (07-DW-001-TAB)JXI · Traditional | Biocircuit Technologies, Inc. | 04/02/2025SE |
| K233322 | Mochida Nerve CuffJXI · Traditional | Mochida Pharmaceutical Co., Ltd. | 06/21/2024SE |
| K233533 | NerveTapeJXI · Traditional | Biocircuit Technologies, Inc. | 02/12/2024SE |
| K230794 | Rebuilder Nerve Guidance ConduitJXI · Traditional | Celestray Biotech Company, LLC., | 01/29/2024SE |
| K232029 | VersaWrap Nerve ProtectorJXI · Traditional | Alafair Biosciences, Inc. | 11/02/2023SE |
More from Alafair Biosciences, Inc.
Questions and answers
When was AxoGen Nerve Cap cleared by the FDA?
AxoGen Nerve Cap (K163446) received a 510(k) decision of Substantially Equivalent on August 8, 2017, 243 days after the submission was received.
What is the product code of K163446?
The FDA product code is JXI – Cuff, Nerve, a Class II (moderate risk) device regulated under 21 CFR 882.5275.