JXI
- Product code
- JXI
- Device name
- Cuff, Nerve
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.5275
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 11
- Summaries archived here
- 11 (direct download)
- 510(k) clearances (all years, FDA)
- 40 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (11)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260245 | 2026-04-09 | KLISBio S.r.l. | SILKBridge | |
| K253363 | 2026-01-17 | Auxilium Biotechnologies, Inc. | NeuroSpan Bridge | |
| K251505 | 2025-07-22 | Alafair Biosciences | VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerv… | |
| K251175 | 2025-07-17 | Alafair Biosciences | VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerv… | |
| K243889 | 2025-04-02 | Orthocell, Ltd. | Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x … | |
| K242113 | 2025-04-02 | Biocircuit Technologies, Inc. | Nerve Wrap (07-DW-001-TAB) | |
| K233322 | 2024-06-21 | Mochida Pharmaceutical Co., Ltd. | Mochida Nerve Cuff | |
| K233533 | 2024-02-12 | Biocircuit Technologies, Inc. | NerveTape | |
| K230794 | 2024-01-29 | Celestray Biotech Company, LLC., | Rebuilder Nerve Guidance Conduit | |
| K232029 | 2023-11-02 | Alafair Biosciences, Inc. | VersaWrap Nerve Protector | |
| K231708 | 2023-10-12 | Axogen Corporation | Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ … |
Official FDA classification page: JXI
Classification and pathway per current FDA publications. Data from openFDA (CC0).