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FDA 510(k)

Reinforced Flexible Collagen Nerve Cuff

K-Number: K170656 · 2017-06-01

ApplicantCollagen Matrix, Inc.
Decision Date2017-06-01
Product CodeJXI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Reinforced Flexible Collagen Nerve Cuff is a medical device manufactured by Collagen Matrix, Inc.. It received FDA 510(k) clearance on 2017-06-01 under approval number K170656. 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 Reinforced Flexible Collagen Nerve Cuff?

Reinforced Flexible Collagen Nerve Cuff is a medical device that received FDA 510(k) clearance on 2017-06-01. It is manufactured by Collagen Matrix, Inc.. The 510(k) number is K170656.

When was Reinforced Flexible Collagen Nerve Cuff approved by the FDA?

Reinforced Flexible Collagen Nerve Cuff received FDA 510(k) clearance on 2017-06-01, under approval number K170656.

What company makes Reinforced Flexible Collagen Nerve Cuff?

Reinforced Flexible Collagen Nerve Cuff is manufactured by Collagen Matrix, Inc..

What is the FDA product code for Reinforced Flexible Collagen Nerve Cuff?

The FDA product code for Reinforced Flexible Collagen Nerve Cuff is JXI.

Related Clinical Trials

NCT07360730 High-Purity Type I Collagen Nerve Wrapping in Peripheral Nerve Procedures: A Prospective Registry COMPLETED

Other Devices by Collagen Matrix, Inc.

K152600Collagen Dental Wound Dressings K171008Anorganic Bone Mineral with Collagen in Delivery Applicator K170541Anorganic Bone Mineral in Delivery Applicator K162158Porcine Anorganic Bone Mineral in Delivery Applicator K182074Mineral Collagen Composite Bioactive Moldable K201859Porcine Mineral Collagen Composite Moldable

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Related Devices (Code: JXI)

K162741AxoGuard Nerve ConnectorCook Biotech Incorporated K152967NERBRIDGEToyobo Co., Ltd. K152684Nerve Capping DevicePolyganics Innovations BV K163446AxoGen Nerve CapAxogen Corporation K163457NeuraGen 3D Nerve Guide MatrixIntegra LifeSciences Corporation K180222Reaxon PlusMedovent GmbH

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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