VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)
FDA 510(k) K251505 · Alafair Biosciences
510(k) numberK251505
Submission
- Device name
- VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)
- Applicant
- Alafair Biosciences
Austin, TX, US - Received
- May 16, 2025
- Decision date
- July 22, 2025
- 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 |
| 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 |
| K231708 | Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard…JXI · Traditional | Axogen Corporation | 10/12/2023SE |
More from Axogen Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K251655 | VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1)OWW · Traditional | 07/18/2025SE |
| K251175 | VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201)JXI · Traditional | 07/17/2025SE |
| K240817 | VersaWrapOWW · Traditional | 06/14/2024SE |
| K232029 | VersaWrap Nerve ProtectorJXI · Traditional | 11/02/2023SE |
| K213163 | VersaWrapFTM · Special | 10/29/2021SE |
| K203600 | VersaWrapFTM · Traditional | 03/09/2021SE |
| K201631 | VersaWrap Nerve ProtectorJXI · Traditional | 09/14/2020SE |
| K200311 | VersaWrap Tendon ProtectorFTM · Special | 03/06/2020SE |
| K160364 | VersaWrap Tendon ProtectorOWW · Traditional | 06/10/2016SE |
Questions and answers
When was VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1) cleared by the FDA?
VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1) (K251505) received a 510(k) decision of Substantially Equivalent on July 22, 2025, 67 days after the submission was received.
What is the product code of K251505?
The FDA product code is JXI – Cuff, Nerve, a Class II (moderate risk) device regulated under 21 CFR 882.5275.