Cuff, Nerve
FDA product code JXI · Class II (moderate risk) · 21 CFR 882.5275 · Neurology
40510(k) clearances
0PMA approvals
4recalls
Implantimplanted device
Manufacturers
- Integra LifeSciences Corp. 4
- Collagen Matrix, Inc. 4
- Alafair Biosciences, Inc. 4
- Cook Biotech, Inc. 3
- Polyganics B.V., 3
- Axogen Corporation 3
- Biocircuit Technologies, Inc. 3
- Salumedica, LLC 2
- Medovent GmbH 2
- Toyobo Co., Ltd. 1
- KLISBio S.r.l. 1
- Auxilium Biotechnologies, Inc. 1
- Orthocell, Ltd. 1
- Mochida Pharmaceutical Co., Ltd. 1
- Celestray Biotech Company, LLC., 1
- Renerve, Ltd. 1
- Monarch Bioimplants GmbH 1
- Research Medical, Inc. 1
- Polyganics Innovations BV 1
- Biom'Up Sas 1
510(k) clearances
| 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 |
| K251505 | VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)JXI · Traditional | Alafair Biosciences | 07/22/2025SE |
| 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 |
| K223640 | Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard…JXI · Traditional | Axogen Corporation | 04/07/2023SE |
| K210665 | Nerve TapeJXI · Traditional | Biocircuit Technologies, Incorporated | 07/15/2022SE |
| K202234 | NervAlign Nerve CuffJXI · Traditional | Renerve, Ltd. | 02/10/2022SE |
| K201631 | VersaWrap Nerve ProtectorJXI · Traditional | Alafair Biosciences, Inc. | 09/14/2020SE |
| K190246 | NeuroShieldJXI · Traditional | Monarch Bioimplants GmbH | 05/31/2019SE |
| K180222 | Reaxon PlusJXI · Traditional | Medovent GmbH | 04/24/2018SE |
| K163446 | AxoGen Nerve CapJXI · Traditional | Axogen Corporation | 08/08/2017SE |
| K170656 | Reinforced Flexible Collagen Nerve CuffJXI · Traditional | Collagen Matrix, Inc. | 06/01/2017SE |
| K163457 | NeuraGen 3D Nerve Guide MatrixJXI · Special | Integra LifeSciences Corporation | 01/06/2017SE |
| K162741 | AxoGuard Nerve ConnectorJXI · Special | Cook Biotech Incorporated | 10/31/2016SE |
| K152967 | NerbridgeJXI · Traditional | Toyobo Co., Ltd. | 06/22/2016SE |
| K152684 | Nerve Capping DeviceJXI · Traditional | Polyganics Innovations BV | 01/13/2016SE |
| K143711 | Reaxon PlusJXI · Traditional | Medovent GmbH | 12/02/2015SE |
| K130557 | Neuragen 3DJXI · Traditional | Integra LifeSciences Corporation | 04/24/2014SE |
| K131541 | Flexible Cooagen Nerve CuffJXI · Traditional | Collagen Matrix, Inc. | 04/03/2014SE |
| K132660 | Nerve CuffJXI · Traditional | Cook Biotech Incorporated | 01/10/2014SE |
| K103081 | Covaortho-Nerve Resorbable Collagen MembraneJXI · Traditional | Biom'Up Sas | 03/02/2012SE |
| K112267 | Neurolac(R) Nerve GuideJXI · Special | Polyganics B.V., | 10/20/2011SE |
| K100382 | Salutunnel Nerve Protector, Model ED-20329, ED-20330, ED-20331JXI · Traditional | Salumedica, LLC | 08/05/2010SE |
| K060952 | Collagen Nerve WrapJXI · Traditional | Collagen Matrix, Inc. | 07/14/2006SE |
| K050573 | Neurolac Nerve GuideJXI · Traditional | Polyganics B.V., | 05/04/2005SE |
| K041620 | Neura Wrap Nerve ProtectorJXI · Traditional | Integra Lifesciences Corp. | 07/16/2004SE |
| K032115 | Neurolac Nerve Guide Models NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03JXI · Traditional | Polyganics B.V., | 10/10/2003SE |
| K031069 | Surgisis Nerve CuffJXI · Traditional | Cook Biotech, Inc. | 05/15/2003SE |
| K012814 | Collagen Nerve CuffJXI · Traditional | Collagen Matrix, Inc. | 09/21/2001SE |
| K011168 | Neurogen Nerve GuideJXI · Traditional | Integra Lifesciences Corp. | 06/22/2001SE |
| K002098 | Salumedica Nerve CuffJXI · Traditional | Salumedica, LLC | 11/24/2000SE |
| K983007 | NeurotubeJXI · Traditional | Neuroregen, LLC | 03/22/1999SE |
| K850785 | Fastube Nerve Regeneration DeviceJXI · Traditional | Research Medical, Inc. | 07/10/1985SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1461-2023 Class II | GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a)…The product is brittle and potentially crumbling upon handling or when being removed from its package. | Baxter Healthcare Corporation | 03/27/2023Open, Classified |
| Z-1470-2020 Class III | NeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 - Product Usage:…Nonconforming product which was dispositioned for rejection was mistakenly released for commercial use. | Integra LifeSciences Corp. | 02/07/2020Terminated |
| Z-1287-2013 Class II | NeuraGen Nerve Guide NeuraGen Nerve Guide is indicated for repair of peripheral nerve…Due to the process deviation, product lots in question may have been released with higher levels of pyrogens… | Integra LifeSciences Corporation | 03/28/2013Terminated |
| Z-1286-2013 Class II | NeuraWrap Nerve Protector NeuraWrap Nerve Protector is indicated for the management of…Due to the process deviation, product lots in question may have been released with higher levels of pyrogens… | Integra LifeSciences Corporation | 03/28/2013Terminated |