Home › Device types › JXI
Cuff, Nerve
FDA product code JXI · Class 2 · Neurology
175
Registered devices
165
Adverse events
4
Recalls
40
510(k) clearances
Devices with this code
NeuraGen® — Integra Lifesciences CorporationRebuilder Nerve Guidance Conduit — Ningbo Guangyuan Zhixin Biological Technology Co., Ltd.NeuroMend — COLLAGEN MATRIX, INC.Nerve Tape® — Biocircuit Technologies, Inc.Remplir™ — ORTHOCELL LIMITEDNeuraGen® 3D — Integra Lifesciences CorporationNeurolac — Polyganics Innovations B.V.Rebuilder Nerve Guidance Conduit — Ningbo Guangyuan Zhixin Biological Technology Co., Ltd.AxoGuard — COOK BIOTECH INCORPORATEDArthrex Nerve Conduit — COLLAGEN MATRIX, INC.NeuroFlex — COLLAGEN MATRIX, INC.Nerbridge® — TOYOBO CO., LTD.NeuraWrap® — Integra Lifesciences CorporationNeuroFlex — COLLAGEN MATRIX, INC.VersaCoat Flowable Hydrogel — Alafair Biosciences, Inc.Arthrex Nerve Wrap — COLLAGEN MATRIX, INC.Rebuilder Nerve Guidance Conduit — Ningbo Guangyuan Zhixin Biological Technology Co., Ltd.Neurolac — Polyganics Innovations B.V.NeuraGen® 3D — Integra Lifesciences CorporationAxoGuard Nerve Cap — AXOGEN CORPORATIONNeuroFlex — COLLAGEN MATRIX, INC.Checkpoint NeuroShield Chitosan Membrane — Checkpoint Surgical, Inc.VersaWrap — Alafair Biosciences, Inc.AxoGuard — COOK BIOTECH INCORPORATED
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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