Atlas FDA

JXI

40 FDA 510(k) clearances · Product code

117 daysmedian time to decision
416 days90th percentile
40clearances measured

FDA profile

Official device name
Cuff, Nerve
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5275
Medical specialty
Neurology
Flags
Implant
Adverse events (MAUDE)
2011: 11 · 2013: 7 · 2014: 7 · 2023: 15 · 2024: 18 · 2025: 18
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
SILKBridge (K260245)KLISBio S.r.l.2026-04-09
NeuroSpan Bridge (K253363)Auxilium Biotechnologies, Inc.2026-01-17
VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1) (K251505)Alafair Biosciences2025-07-22
VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201) (K251175)Alafair Biosciences2025-07-17
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) (K243889)Orthocell, Ltd.2025-04-02
Nerve Wrap (07-DW-001-TAB) (K242113)Biocircuit Technologies, Inc.2025-04-02
Mochida Nerve Cuff (K233322)Mochida Pharmaceutical Co., Ltd.2024-06-21
NerveTape (K233533)Biocircuit Technologies, Inc.2024-02-12
Rebuilder Nerve Guidance Conduit (K230794)Celestray Biotech Company, LLC.,2024-01-29
VersaWrap Nerve Protector (K232029)Alafair Biosciences, Inc.2023-11-02
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) (K231708)Axogen Corporation2023-10-12
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) (K223640)Axogen Corporation2023-04-07
Nerve Tape (K210665)Biocircuit Technologies, Incorporated2022-07-15
NervAlign Nerve Cuff (K202234)Renerve, Ltd.2022-02-10
VersaWrap Nerve Protector (K201631)Alafair Biosciences, Inc.2020-09-14
NeuroShield (K190246)Monarch Bioimplants GmbH2019-05-31
Reaxon Plus (K180222)Medovent GmbH2018-04-24
AxoGen Nerve Cap (K163446)Axogen Corporation2017-08-08
Reinforced Flexible Collagen Nerve Cuff (K170656)Collagen Matrix, Inc.2017-06-01
NeuraGen 3D Nerve Guide Matrix (K163457)Integra LifeSciences Corporation2017-01-06
AxoGuard Nerve Connector (K162741)Cook Biotech Incorporated2016-10-31
NERBRIDGE (K152967)Toyobo Co., Ltd.2016-06-22
Nerve Capping Device (K152684)Polyganics Innovations BV2016-01-13
Reaxon Plus (K143711)Medovent GmbH2015-12-02
NEURAGEN 3D (K130557)Integra LifeSciences Corporation2014-04-24
FLEXIBLE COOAGEN NERVE CUFF (K131541)Collagen Matrix, Inc.2014-04-03
NERVE CUFF (K132660)Cook Biotech Incorporated2014-01-10
COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE (K103081)Biom'Up Sas2012-03-02
NEUROLAC(R) NERVE GUIDE (K112267)Polyganics B.V.,2011-10-20
SALUTUNNEL NERVE PROTECTOR, MODEL ED-20329, ED-20330, ED-20331 (K100382)Salumedica, LLC2010-08-05
COLLAGEN NERVE WRAP (K060952)Collagen Matrix, Inc.2006-07-14
NEUROLAC NERVE GUIDE (K050573)Polyganics B.V.,2005-05-04
NEURA WRAP NERVE PROTECTOR (K041620)Integra Lifesciences Corp.2004-07-16
NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03 (K032115)Polyganics B.V.,2003-10-10
SURGISIS NERVE CUFF (K031069)Cook Biotech, Inc.2003-05-15
COLLAGEN NERVE CUFF (K012814)Collagen Matrix, Inc.2001-09-21
NEUROGEN NERVE GUIDE (K011168)Integra Lifesciences Corp.2001-06-22
SALUMEDICA NERVE CUFF (K002098)Salumedica, LLC2000-11-24
NEUROTUBE (K983007)Neuroregen, LLC1999-03-22
FASTUBE NERVE REGENERATION DEVICE (K850785)Research Medical, Inc.1985-07-10

Track JXI automatically

Every clearance here is in the API, with alerts when new ones post.