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FDA 510(k)

Durepair Dura Regeneration Matrix

K-Number: K161370 · 2016-11-02

ApplicantMedtronic Neurosurgery
Decision Date2016-11-02
Product CodeGXQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Durepair Dura Regeneration Matrix is a medical device manufactured by Medtronic Neurosurgery. It received FDA 510(k) clearance on 2016-11-02 under approval number K161370. The device is classified under product code GXQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Durepair Dura Regeneration Matrix?

Durepair Dura Regeneration Matrix is a medical device that received FDA 510(k) clearance on 2016-11-02. It is manufactured by Medtronic Neurosurgery. The 510(k) number is K161370.

When was Durepair Dura Regeneration Matrix approved by the FDA?

Durepair Dura Regeneration Matrix received FDA 510(k) clearance on 2016-11-02, under approval number K161370.

What company makes Durepair Dura Regeneration Matrix?

Durepair Dura Regeneration Matrix is manufactured by Medtronic Neurosurgery.

What is the FDA product code for Durepair Dura Regeneration Matrix?

The FDA product code for Durepair Dura Regeneration Matrix is GXQ.

Related Clinical Trials

NCT03164122 EVALUATION OF AN INNOVATIVE TREATMENT FOR RADIOCARPAL OSTEOARTHRITIS USING INTRA-ARTICULAR INJECTION OF A MIXTURE OF AUTOLOGOUS MICROFAT AND AUTOLOGOUS PLATELET-RICH PLASMA COMPLETED NCT07546279 The Use of Two Bone Substitutes in Adjunct to EMD for the Treatment of One- and Two-wall Intrabony Defects. RECRUITING

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Related Devices (Code: GXQ)

K161278Cerafix Dura SubstituteAcera Surgical, Inc. K153613Cerafix Dura SubstituteAcera Surgical, Inc. K172603Cerafix Dura SubstituteAcera Surgical, Inc. K163456DuraGen Secure Dural Regeneration MatrixIntegra LifeSciences Corporation K183513XenoSure Dura Biologic PatchLeMaitre Vascular, Inc. K212943SyntheCel Dura RepairSynthes (USA) Products, LLC

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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