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FDA 510(k)

NervAlign Nerve Cuff

K-Number: K202234 · 2022-02-10

ApplicantRenerve, Ltd.
Decision Date2022-02-10
Product CodeJXI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NervAlign Nerve Cuff is a medical device manufactured by Renerve, Ltd.. It received FDA 510(k) clearance on 2022-02-10 under approval number K202234. The device is classified under product code JXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NervAlign Nerve Cuff?

NervAlign Nerve Cuff is a medical device that received FDA 510(k) clearance on 2022-02-10. It is manufactured by Renerve, Ltd.. The 510(k) number is K202234.

When was NervAlign Nerve Cuff approved by the FDA?

NervAlign Nerve Cuff received FDA 510(k) clearance on 2022-02-10, under approval number K202234.

What company makes NervAlign Nerve Cuff?

NervAlign Nerve Cuff is manufactured by Renerve, Ltd..

What is the FDA product code for NervAlign Nerve Cuff?

The FDA product code for NervAlign Nerve Cuff is JXI.

Related Devices (Code: JXI)

K162741AxoGuard Nerve ConnectorCook Biotech Incorporated K152967NERBRIDGEToyobo Co., Ltd. K152684Nerve Capping DevicePolyganics Innovations BV K163446AxoGen Nerve CapAxogen Corporation K170656Reinforced Flexible Collagen Nerve CuffCollagen Matrix, Inc. K163457NeuraGen 3D Nerve Guide MatrixIntegra LifeSciences Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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