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FDA 510(k)

Collagen Dura Regeneration Membrane - Repair

K-Number: K251191 · 2025-11-18

ApplicantCollagen Matrix, Inc.
Decision Date2025-11-18
Product CodeGXQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Collagen Dura Regeneration Membrane - Repair is the device name listed in this FDA 510(k) record. The listed applicant is Collagen Matrix, Inc.. It received FDA 510(k) clearance on 2025-11-18 under 510(k) number K251191. 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 Collagen Dura Regeneration Membrane - Repair?

Collagen Dura Regeneration Membrane - Repair is a medical device that received FDA 510(k) clearance on 2025-11-18. The listed applicant is Collagen Matrix, Inc.. The 510(k) number is K251191.

When did Collagen Dura Regeneration Membrane - Repair receive FDA 510(k) clearance?

Collagen Dura Regeneration Membrane - Repair received FDA 510(k) clearance on 2025-11-18, under 510(k) number K251191.

Who is the listed applicant for Collagen Dura Regeneration Membrane - Repair?

The FDA 510(k) record lists Collagen Matrix, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Collagen Dura Regeneration Membrane - Repair?

The FDA product code for Collagen Dura Regeneration Membrane - Repair is GXQ.

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Other records listing Collagen Matrix, Inc. 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.

K243071Bovine Dermis Collagen Dermal MatrixK242302RejuvaKnee™ Collagen Meniscus ImplantK233203Soft Tissue Augmentation Resorbable MatrixK240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixK231942Mineral Collagen Composite Bioactive Extra MoldableK221735Mineral Collagen Composite Bioactive Moldable

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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.

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.K163456DuraGen Secure Dural Regeneration 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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