Product code JXI
- Device name
- Cuff, Nerve
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.5275
- Review panel
- NE
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260245 | SILKBridge | KLISBio S.r.l. | 2026-04-09 |
| K253363 | NeuroSpan Bridge | Auxilium Biotechnologies, Inc. | 2026-01-17 |
| K251505 | VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1) | Alafair Biosciences | 2025-07-22 |
| K251175 | VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201) | Alafair Biosciences | 2025-07-17 |
| 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. | 2025-04-02 |
| K242113 | Nerve Wrap (07-DW-001-TAB) | Biocircuit Technologies, Inc. | 2025-04-02 |
| K233322 | Mochida Nerve Cuff | Mochida Pharmaceutical Co., Ltd. | 2024-06-21 |
| K233533 | NerveTape | Biocircuit Technologies, Inc. | 2024-02-12 |
| K230794 | Rebuilder Nerve Guidance Conduit | Celestray Biotech Company, LLC., | 2024-01-29 |
| K232029 | VersaWrap Nerve Protector | Alafair Biosciences, Inc. | 2023-11-02 |
| 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 | 2023-10-12 |
| 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 | 2023-04-07 |
| K210665 | Nerve Tape | Biocircuit Technologies, Incorporated | 2022-07-15 |
| K202234 | NervAlign Nerve Cuff | Renerve, Ltd. | 2022-02-10 |
| K201631 | VersaWrap Nerve Protector | Alafair Biosciences, Inc. | 2020-09-14 |
| K190246 | NeuroShield | Monarch Bioimplants GmbH | 2019-05-31 |
| K180222 | Reaxon Plus | Medovent GmbH | 2018-04-24 |
| K163446 | AxoGen Nerve Cap | Axogen Corporation | 2017-08-08 |
| K170656 | Reinforced Flexible Collagen Nerve Cuff | Collagen Matrix, Inc. | 2017-06-01 |
| K163457 | NeuraGen 3D Nerve Guide Matrix | Integra LifeSciences Corporation | 2017-01-06 |
| K162741 | AxoGuard Nerve Connector | Cook Biotech Incorporated | 2016-10-31 |
| K152967 | NERBRIDGE | Toyobo Co., Ltd. | 2016-06-22 |
| K152684 | Nerve Capping Device | Polyganics Innovations BV | 2016-01-13 |
| K143711 | Reaxon Plus | Medovent GmbH | 2015-12-02 |
| K130557 | NEURAGEN 3D | Integra LifeSciences Corporation | 2014-04-24 |
| K131541 | FLEXIBLE COOAGEN NERVE CUFF | Collagen Matrix, Inc. | 2014-04-03 |
| K132660 | NERVE CUFF | Cook Biotech Incorporated | 2014-01-10 |
| K103081 | COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE | Biom'Up Sas | 2012-03-02 |
| K112267 | NEUROLAC(R) NERVE GUIDE | Polyganics B.V., | 2011-10-20 |
| K100382 | SALUTUNNEL NERVE PROTECTOR, MODEL ED-20329, ED-20330, ED-20331 | Salumedica, LLC | 2010-08-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B454VTP12G10 | VersaCoat Flowable Hydrogel | Alafair Biosciences, Inc. | 2025-12-21 |
| B454VTP44G20 | VersaCoat Flowable Hydrogel | Alafair Biosciences, Inc. | 2025-11-21 |
| G517CW2040 | ConformaWrap | Biocircuit Technologies, Inc. | 2025-09-10 |
| G517CW4080 | ConformaWrap | Biocircuit Technologies, Inc. | 2025-09-10 |
| 00813954027302 | Arthrex Nerve Conduit | COLLAGEN MATRIX, INC. | 2025-07-25 |
| 00813954027296 | Arthrex Nerve Conduit | COLLAGEN MATRIX, INC. | 2025-07-25 |
| 00813954027289 | Arthrex Nerve Conduit | COLLAGEN MATRIX, INC. | 2025-07-25 |
| 00813954027272 | Arthrex Nerve Conduit | COLLAGEN MATRIX, INC. | 2025-07-25 |
| 00813954027319 | Arthrex Nerve Conduit | COLLAGEN MATRIX, INC. | 2025-07-25 |
| 00813954027326 | Arthrex Nerve Conduit | COLLAGEN MATRIX, INC. | 2025-07-25 |
| 00813954027333 | Arthrex Nerve Wrap | COLLAGEN MATRIX, INC. | 2025-07-25 |
| 00813954027340 | Arthrex Nerve Wrap | COLLAGEN MATRIX, INC. | 2025-07-25 |
| 00813954027357 | Arthrex Nerve Wrap | COLLAGEN MATRIX, INC. | 2025-07-25 |
| 00813954027364 | Arthrex Nerve Wrap | COLLAGEN MATRIX, INC. | 2025-07-25 |
| 00813954027371 | Arthrex Nerve Wrap | COLLAGEN MATRIX, INC. | 2025-07-25 |
| 00813954027388 | Arthrex Nerve Wrap | COLLAGEN MATRIX, INC. | 2025-07-25 |
| 06975222390007 | Rebuilder Nerve Guidance Conduit | Ningbo Guangyuan Zhixin Biological Technology Co., Ltd. | 2025-05-20 |
| 06975222390014 | Rebuilder Nerve Guidance Conduit | Ningbo Guangyuan Zhixin Biological Technology Co., Ltd. | 2025-05-20 |
| 06975222390021 | Rebuilder Nerve Guidance Conduit | Ningbo Guangyuan Zhixin Biological Technology Co., Ltd. | 2025-05-20 |
| 09358206000074 | Remplir™ | ORTHOCELL LIMITED | 2025-04-07 |
| 09358206000043 | Remplir™ | ORTHOCELL LIMITED | 2025-04-07 |
| 00850828007145 | Axoguard HA+ Nerve Protector | AXOGEN CORPORATION | 2023-04-24 |
| 00850828007138 | Axoguard HA+ Nerve Protector | AXOGEN CORPORATION | 2023-04-24 |
| 00850828007121 | Axoguard HA+ Nerve Protector | AXOGEN CORPORATION | 2023-04-24 |
| 00850828007114 | Axoguard HA+ Nerve Protector | AXOGEN CORPORATION | 2023-04-24 |
| 00850828007107 | Axoguard HA+ Nerve Protector | AXOGEN CORPORATION | 2023-04-24 |
| B130PV40300 | ProVeil Hydrogel Membrane | Checkpoint Surgical, Inc. | 2023-03-31 |
| B130NS30200 | Checkpoint NeuroShield Chitosan Membrane | Checkpoint Surgical, Inc. | 2023-03-31 |
| 07640181711017 | NeuroShield | Monarch Bioimplants GmbH | 2022-09-06 |
| 07640181710010 | NeuroShield | Monarch Bioimplants GmbH | 2022-04-20 |