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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 the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Neurosurgery. It received FDA 510(k) clearance on 2016-11-02 under 510(k) 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. The listed applicant is Medtronic Neurosurgery. The 510(k) number is K161370.

When did Durepair Dura Regeneration Matrix receive FDA 510(k) clearance?

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

Who is the listed applicant for Durepair Dura Regeneration Matrix?

The FDA 510(k) record lists Medtronic Neurosurgery as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Medtronic Neurosurgery as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: GXQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251191Collagen Dura Regeneration Membrane - RepairCollagen Matrix, Inc.K250420Helios Dura Regeneration MatrixHelios Biomedical, Inc.K223445ArtiFasciaNurami Medical , Ltd.K212943SyntheCel Dura RepairSynthes (USA) Products, LLCK183513XenoSure Dura Biologic PatchLeMaitre Vascular, Inc.K172603Cerafix Dura SubstituteAcera Surgical, Inc.

Official Source

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

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