FDA Product Code
FDA Product Code JXI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.5275
510(k) Clearances — 40 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260245 | SILKBridge | KLISBio S.r.l. | 2026-04-09 | Traditional | PDF ↗ |
| K253363 | NeuroSpan Bridge | Auxilium Biotechnologies, Inc. | 2026-01-17 | Traditional | PDF ↗ |
| K251505 | VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1) | Alafair Biosciences | 2025-07-22 | Traditional | PDF ↗ |
| K251175 | VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201) | Alafair Biosciences | 2025-07-17 | Traditional | PDF ↗ |
| K242113 | Nerve Wrap (07-DW-001-TAB) | Biocircuit Technologies, Inc. | 2025-04-02 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K233322 | Mochida Nerve Cuff | Mochida Pharmaceutical Co., Ltd. | 2024-06-21 | Traditional | PDF ↗ |
| K233533 | NerveTape | Biocircuit Technologies, Inc. | 2024-02-12 | Traditional | PDF ↗ |
| K230794 | Rebuilder Nerve Guidance Conduit | Celestray Biotech Company, LLC., | 2024-01-29 | Traditional | PDF ↗ |
| K232029 | VersaWrap Nerve Protector | Alafair Biosciences, Inc. | 2023-11-02 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K210665 | Nerve Tape | Biocircuit Technologies, Incorporated | 2022-07-15 | Traditional | PDF ↗ |
| K202234 | NervAlign Nerve Cuff | Renerve, Ltd. | 2022-02-10 | Traditional | PDF ↗ |
| K201631 | VersaWrap Nerve Protector | Alafair Biosciences, Inc. | 2020-09-14 | Traditional | PDF ↗ |
| K190246 | NeuroShield | Monarch Bioimplants GmbH | 2019-05-31 | Traditional | PDF ↗ |
| K180222 | Reaxon Plus | Medovent GmbH | 2018-04-24 | Traditional | PDF ↗ |
| K163446 | AxoGen Nerve Cap | Axogen Corporation | 2017-08-08 | Traditional | PDF ↗ |
| K170656 | Reinforced Flexible Collagen Nerve Cuff | Collagen Matrix, Inc. | 2017-06-01 | Traditional | PDF ↗ |
| K163457 | NeuraGen 3D Nerve Guide Matrix | Integra LifeSciences Corporation | 2017-01-06 | Special | PDF ↗ |
| K162741 | AxoGuard Nerve Connector | Cook Biotech Incorporated | 2016-10-31 | Special | PDF ↗ |
| K152967 | NERBRIDGE | Toyobo Co., Ltd. | 2016-06-22 | Traditional | PDF ↗ |
| K152684 | Nerve Capping Device | Polyganics Innovations BV | 2016-01-13 | Traditional | PDF ↗ |
| K143711 | Reaxon Plus | Medovent GmbH | 2015-12-02 | Traditional | PDF ↗ |
| K130557 | NEURAGEN 3D | Integra LifeSciences Corporation | 2014-04-24 | Traditional | PDF ↗ |
| K131541 | FLEXIBLE COOAGEN NERVE CUFF | Collagen Matrix, Inc. | 2014-04-03 | Traditional | PDF ↗ |
| K132660 | NERVE CUFF | Cook Biotech Incorporated | 2014-01-10 | Traditional | PDF ↗ |
| K103081 | COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE | Biom'Up Sas | 2012-03-02 | Traditional | PDF ↗ |
| K112267 | NEUROLAC(R) NERVE GUIDE | Polyganics B.V., | 2011-10-20 | Special | PDF ↗ |
| K100382 | SALUTUNNEL NERVE PROTECTOR, MODEL ED-20329, ED-20330, ED-20331 | Salumedica, LLC | 2010-08-05 | Traditional | PDF ↗ |
| K060952 | COLLAGEN NERVE WRAP | Collagen Matrix, Inc. | 2006-07-14 | Traditional | PDF ↗ |
| K050573 | NEUROLAC NERVE GUIDE | Polyganics B.V., | 2005-05-04 | Traditional | PDF ↗ |
| K041620 | NEURA WRAP NERVE PROTECTOR | Integra Lifesciences Corp. | 2004-07-16 | Traditional | PDF ↗ |
| K032115 | NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03 | Polyganics B.V., | 2003-10-10 | Traditional | PDF ↗ |
| K031069 | SURGISIS NERVE CUFF | Cook Biotech, Inc. | 2003-05-15 | Traditional | PDF ↗ |
| K012814 | COLLAGEN NERVE CUFF | Collagen Matrix, Inc. | 2001-09-21 | Traditional | PDF ↗ |
| K011168 | NEUROGEN NERVE GUIDE | Integra Lifesciences Corp. | 2001-06-22 | Traditional | PDF ↗ |
| K002098 | SALUMEDICA NERVE CUFF | Salumedica, LLC | 2000-11-24 | Traditional | PDF ↗ |
| K983007 | NEUROTUBE | Neuroregen, LLC | 1999-03-22 | Traditional | PDF ↗ |
| K850785 | FASTUBE NERVE REGENERATION DEVICE | Research Medical, Inc. | 1985-07-10 | Traditional | PDF ↗ |
Product code JXI · Class II · Neurology. Data: openFDA.