Home › Device types › JXI
Cuff, Nerve
FDA product code JXI · Class 2 · Neurology
179
Registered devices
174
Adverse events
4
Recalls
40
510(k) clearances
Devices with this code
NeuraGen® 3D — Integra Lifesciences CorporationSILKBridge — KLISBIO SRLCOVAORTHO-NERVE — DILON TECHNOLOGIES FRANCENeurolac TW — Polyganics Innovations B.V.NeuroMend — COLLAGEN MATRIX, INC.Rebuilder Nerve Guidance Conduit — Ningbo Guangyuan Zhixin Biological Technology Co., Ltd.AxoGuard — COOK BIOTECH INCORPORATEDAxoguard HA+ Nerve Protector — AXOGEN CORPORATIONNeuraGen® — Integra Lifesciences CorporationCOVA ORTHO NERVE — DILON TECHNOLOGIES FRANCENeuraWrap® — Integra Lifesciences CorporationNeuraGen® 3D — Integra Lifesciences CorporationNeuroShield — Monarch Bioimplants GmbHNerve Tape® — Biocircuit Technologies, Inc.Rebuilder Nerve Guidance Conduit — Ningbo Guangyuan Zhixin Biological Technology Co., Ltd.AxoGuard — COOK BIOTECH INCORPORATEDNerbridge® — TOYOBO CO., LTD.AxoGuard — COOK BIOTECH INCORPORATEDAxoGuard Nerve Cap — AXOGEN CORPORATIONCheckpoint NeuroShield Chitosan Membrane — Checkpoint Surgical, Inc.NeuraGen® — Integra Lifesciences CorporationArthrex Nerve Wrap — COLLAGEN MATRIX, INC.Nerbridge® — TOYOBO CO., LTD.Axoguard HA+ Nerve Protector — AXOGEN CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-03-27 | Baxter Healthcare Corporation | The product is brittle and potentially crumbling upon handling or when being removed from its package. |
| 2020-02-07 | Integra LifeSciences Corp. | Nonconforming product which was dispositioned for rejection was mistakenly released for commercial use. |
| 2013-03-28 | Integra LifeSciences Corporation | Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the produc |
| 2013-03-28 | Integra LifeSciences Corporation | Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the produc |
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