JXI · Cuff, Nerve
Neurology · 21 CFR 882.5275 · Class 2
Overview
| Product Code | JXI |
|---|---|
| Device Name | Cuff, Nerve |
| Regulation | 21 CFR 882.5275 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| Implant | Yes |
Identification
A nerve cuff is a tubular silicone rubber sheath used to encase a nerve for aid in repairing the nerve (e.g., to prevent ingrowth of scar tissue) and for capping the end of the nerve to prevent the formation of neuroma (tumors).
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 40)
Showing 20 most recent of 40 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260245 | SILKBridge | KLISBio S.r.l. | Apr 9, 2026 | SESE |
| K253363 | NeuroSpan Bridge | Auxilium Biotechnologies, Inc. | Jan 17, 2026 | SESE |
| K251505 | VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1) | Alafair Biosciences | Jul 22, 2025 | SESE |
| K251175 | VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201) | Alafair Biosciences | Jul 17, 2025 | SESE |
| K243889 | Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm) | Orthocell, Ltd. | Apr 2, 2025 | SESE |
| K242113 | Nerve Wrap (07-DW-001-TAB) | Biocircuit Technologies, Inc. | Apr 2, 2025 | SESE |
| K233322 | Mochida Nerve Cuff | Mochida Pharmaceutical Co., Ltd. | Jun 21, 2024 | SESE |
| K233533 | NerveTape | Biocircuit Technologies, Inc. | Feb 12, 2024 | SESE |
| K230794 | Rebuilder Nerve Guidance Conduit | Celestray Biotech Company, LLC., | Jan 29, 2024 | SESE |
| K232029 | VersaWrap Nerve Protector | Alafair Biosciences, Inc. | Nov 2, 2023 | SESE |
| 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) | Axogen Corporation | Oct 12, 2023 | SESE |
| K223640 | 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) | Axogen Corporation | Apr 7, 2023 | SESE |
| K210665 | Nerve Tape | Biocircuit Technologies, Incorporated | Jul 15, 2022 | SESE |
| K202234 | NervAlign Nerve Cuff | Renerve, Ltd. | Feb 10, 2022 | SESE |
| K201631 | VersaWrap Nerve Protector | Alafair Biosciences, Inc. | Sep 14, 2020 | SESE |
| K190246 | NeuroShield | Monarch Bioimplants GmbH | May 31, 2019 | SESE |
| K180222 | Reaxon Plus | Medovent GmbH | Apr 24, 2018 | SESE |
| K163446 | AxoGen Nerve Cap | Axogen Corporation | Aug 8, 2017 | SESE |
| K170656 | Reinforced Flexible Collagen Nerve Cuff | Collagen Matrix, Inc. | Jun 1, 2017 | SESE |
| K163457 | NeuraGen 3D Nerve Guide Matrix | Integra LifeSciences Corporation | Jan 6, 2017 | SESE |
Top Applicants
- Collagen Matrix, Inc. — 4 clearances
- Axogen Corporation — 3 clearances
- Polyganics B.V., — 3 clearances
- Alafair Biosciences — 2 clearances
- Alafair Biosciences, Inc. — 2 clearances
