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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 a medical device manufactured by Collagen Matrix, Inc.. It received FDA 510(k) clearance on 2025-11-18 under approval 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. It is manufactured by Collagen Matrix, Inc.. The 510(k) number is K251191.

When was Collagen Dura Regeneration Membrane - Repair approved by the FDA?

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

What company makes Collagen Dura Regeneration Membrane - Repair?

Collagen Dura Regeneration Membrane - Repair is manufactured by Collagen Matrix, Inc..

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

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

Related Clinical Trials

NCT06335628 Volumetric Dimensional Changes After Surgical Pontic Site Development Procedures With Connective Tissue Graft or Collagen Matrix RECRUITING NCT07409571 Palatal Wound Healing After Free Gingival Graft Surgery RECRUITING NCT07595198 Platelet-Rich Fibrin (PRF) vs Bone Graft With Membrane for Ridge Preservation After Tooth Extraction NOT_YET_RECRUITING NCT07580495 Effect of Collagen Membrane on Ridge Preservation NOT_YET_RECRUITING NCT05463991 Bioengineered Collagen Implant for Urethral Stricture Repair COMPLETED NCT03332238 Stromal Vascular Fraction Cell Therapy to Improve the Repair of Rotator Cuff Tears ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 41470022 Low-intensity pulsed ultrasound for peripheral nerve regeneration: mechanobiological mechanisms and translational potential. Journal of translational medicine (2025) PMID: 40876809 Applications of Tissue-Inducing Biomaterials in Nonosseous Tissues: Evidence Map of Animal Studies. Tissue engineering. Part A (2026) PMID: 40781789 Resorbable Bio-Inductive Collagen Implant for Rotator Cuff Repair: What We Know, What We Need to Know, and the Path Forward. Orthopaedic surgery (2025) PMID: 39933996 Micro/Nanobiomimetic Iron-Based Scaffold Induces Vascularized Bone Regeneration To Repair Large Segmental Bone Defect in Load-Bearing Sites. ACS nano (2025)

Other Devices by Collagen Matrix, Inc.

K152600Collagen Dental Wound Dressings K171008Anorganic Bone Mineral with Collagen in Delivery Applicator K170541Anorganic Bone Mineral in Delivery Applicator K170656Reinforced Flexible Collagen Nerve Cuff K162158Porcine Anorganic Bone Mineral in Delivery Applicator K182074Mineral Collagen Composite Bioactive Moldable

View all 16 devices →

Related Devices (Code: GXQ)

K161370Durepair Dura Regeneration MatrixMedtronic Neurosurgery 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.

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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