JXI — Cuff, Nerve Class II
FDA product code JXI covers "Cuff, Nerve", a Class II medical device regulated under 21 CFR 882.5275. Submissions are reviewed by the Neurology panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JXI
- Device Class
- Class II
- Regulation Number
- 882.5275
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260245 | klisbio | SILKBridge | April 9, 2026 |
| K253363 | auxilium biotechnologies | NeuroSpan Bridge | January 17, 2026 |
| K251505 | alafair biosciences | VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1) | July 22, 2025 |
| K251175 | alafair biosciences | VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201) | July 17, 2025 |
| K242113 | biocircuit technologies | Nerve Wrap (07-DW-001-TAB) | April 2, 2025 |
| K243889 | orthocell | Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 | April 2, 2025 |
| K233322 | mochida pharmaceutical co | Mochida Nerve Cuff | June 21, 2024 |
| K233533 | biocircuit technologies | NerveTape | February 12, 2024 |
| K230794 | celestray biotech company, llc | Rebuilder Nerve Guidance Conduit | January 29, 2024 |
| K232029 | alafair biosciences | VersaWrap Nerve Protector | November 2, 2023 |
| K231708 | axogen corporation | Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Ax | October 12, 2023 |
| K223640 | axogen corporation | Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Ax | April 7, 2023 |
| K210665 | biocircuit technologies, incorporated | Nerve Tape | July 15, 2022 |
| K202234 | renerve | NervAlign Nerve Cuff | February 10, 2022 |
| K201631 | alafair biosciences | VersaWrap Nerve Protector | September 14, 2020 |
| K190246 | monarch bioimplants | NeuroShield | May 31, 2019 |
| K180222 | medovent | Reaxon Plus | April 24, 2018 |
| K163446 | axogen corporation | AxoGen Nerve Cap | August 8, 2017 |
| K170656 | collagen matrix | Reinforced Flexible Collagen Nerve Cuff | June 1, 2017 |
| K163457 | integra lifesciences corporation | NeuraGen 3D Nerve Guide Matrix | January 6, 2017 |