Home / 510(k) Clearances / K141608

510(k) K141608

COLLAGEN DURA MEMBRANE by Collagen Matrix, Inc. — Product Code GXQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 2015
Date Received
June 16, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dura Substitute
Device Class
Class II
Regulation Number
882.5910
Review Panel
NE
Submission Type

Other clearances by Collagen Matrix, Inc.

  • K251191 — Collagen Dura Regeneration Membrane - Repair (November 18, 2025)
  • K243071 — Bovine Dermis Collagen Dermal Matrix (December 19, 2024)
  • K242302 — RejuvaKnee™ Collagen Meniscus Implant (October 2, 2024)
  • K233203 — Soft Tissue Augmentation Resorbable Matrix (May 1, 2024)
  • K240424 — Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix (March 12, 2024)
  • K231942 — Mineral Collagen Composite Bioactive Extra Moldable (August 2, 2023)
  • K221735 — Mineral Collagen Composite Bioactive Moldable (December 20, 2022)
  • K213341 — Fibrillar Collagen Wound Dressing (May 31, 2022)
  • K202183 — Porcine Mineral Collagen Composite (April 2, 2021)
  • K201859 — Porcine Mineral Collagen Composite Moldable (September 11, 2020)

Other clearances for product code GXQ

  • K251191 — Collagen Dura Regeneration Membrane - Repair (November 18, 2025)
  • K250420 — Helios Dura Regeneration Matrix (May 14, 2025)
  • K223445 — ArtiFascia (August 10, 2023)
  • K212943 — SyntheCel Dura Repair (January 28, 2022)
  • K183513 — XenoSure Dura Biologic Patch (June 13, 2019)
  • K172603 — Cerafix Dura Substitute (November 27, 2017)
  • K163456 — DuraGen Secure Dural Regeneration Matrix (January 6, 2017)
  • K161370 — Durepair Dura Regeneration Matrix (November 2, 2016)
  • K161278 — Cerafix Dura Substitute (August 8, 2016)
  • K153613 — Cerafix Dura Substitute (March 16, 2016)