FDA 510(k) Applications for Medical Device Product Code "JXI"
(Cuff, Nerve)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K251505 | Alafair Biosciences | VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1) | 07/22/2025 |
| K251175 | Alafair Biosciences | VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201) | 07/17/2025 |
| K201631 | Alafair Biosciences Inc | VersaWrap Nerve Protector | 09/14/2020 |
| K232029 | Alafair Biosciences Inc | VersaWrap Nerve Protector | 11/02/2023 |
| K163446 | AxoGen Corporation | AxoGen Nerve Cap | 08/08/2017 |
| K223640 | AxoGen Corporation | 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) | 04/07/2023 |
| K231708 | AxoGen Corporation | 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) | 10/12/2023 |
| K242113 | BioCircuit Technologies, Inc. | Nerve Wrap (07-DW-001-TAB) | 04/02/2025 |
| K233533 | BioCircuit Technologies, Inc. | NerveTape | 02/12/2024 |
| K210665 | BioCircuit Technologies, Incorporated | Nerve Tape | 07/15/2022 |
| K103081 | BIOM'UP SAS | COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE | 03/02/2012 |
| K230794 | CelestRay Biotech Company, LLC., | Rebuilder Nerve Guidance Conduit | 01/29/2024 |
| K012814 | COLLAGEN MATRIX, INC. | COLLAGEN NERVE CUFF | 09/21/2001 |
| K060952 | COLLAGEN MATRIX, INC. | COLLAGEN NERVE WRAP | 07/14/2006 |
| K131541 | COLLAGEN MATRIX, INC. | FLEXIBLE COOAGEN NERVE CUFF | 04/03/2014 |
| K170656 | Collagen Matrix, Inc. | Reinforced Flexible Collagen Nerve Cuff | 06/01/2017 |
| K162741 | COOK BIOTECH INCORPORATED | AxoGuard Nerve Connector | 10/31/2016 |
| K132660 | COOK BIOTECH INCORPORATED | NERVE CUFF | 01/10/2014 |
| K031069 | COOK BIOTECH, INC. | SURGISIS NERVE CUFF | 05/15/2003 |
| K041620 | INTEGRA LIFESCIENCES CORP. | NEURA WRAP NERVE PROTECTOR | 07/16/2004 |
| K011168 | INTEGRA LIFESCIENCES CORP. | NEUROGEN NERVE GUIDE | 06/22/2001 |
| K130557 | INTEGRA LIFESCIENCES CORPORATION | NEURAGEN 3D | 04/24/2014 |
| K163457 | Integra LifeSciences Corporation | NeuraGen 3D Nerve Guide Matrix | 01/06/2017 |
| K143711 | MEDOVENT GMBH | Reaxon Plus | 12/02/2015 |
| K180222 | Medovent GmbH | Reaxon Plus | 04/24/2018 |
| K233322 | Mochida Pharmaceutical Co., Ltd. | Mochida Nerve Cuff | 06/21/2024 |
| K190246 | Monarch Bioimplants GmbH | NeuroShield | 05/31/2019 |
| K983007 | NEUROREGEN, L.L.C. | NEUROTUBE | 03/22/1999 |
| K243889 | Orthocell Ltd. | 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) | 04/02/2025 |
| K050573 | Polyganics BV | NEUROLAC NERVE GUIDE | 05/04/2005 |
| K032115 | Polyganics BV | NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03 | 10/10/2003 |
| K112267 | Polyganics BV | NEUROLAC(R) NERVE GUIDE | 10/20/2011 |
| K152684 | POLYGANICS INNOVATIONS BV | Nerve Capping Device | 01/13/2016 |
| K202234 | Renerve Ltd | NervAlign Nerve Cuff | 02/10/2022 |
| K002098 | SALUMEDICA, L.L.C. | SALUMEDICA NERVE CUFF | 11/24/2000 |
| K100382 | SALUMEDICA, L.L.C. | SALUTUNNEL NERVE PROTECTOR, MODEL ED-20329, ED-20330, ED-20331 | 08/05/2010 |
| K152967 | TOYOBO CO., LTD. | NERBRIDGE | 06/22/2016 |
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