Home / 510(k) Clearances / K161278

510(k) K161278

Cerafix Dura Substitute by Acera Surgical, Inc. — Product Code GXQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2016
Date Received
May 6, 2016
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 Acera Surgical, Inc.

  • K251224 — Restrata Soft Tissue Reinforcement (STR) (June 20, 2025)
  • K223725 — Restrata® MiniMatrix (May 18, 2023)
  • K193583 — Restrata® (September 25, 2020)
  • K172603 — Cerafix Dura Substitute (November 27, 2017)
  • K170300 — Restrata Wound Matrix (April 26, 2017)
  • K153613 — Cerafix Dura Substitute (March 16, 2016)

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)
  • K153613 — Cerafix Dura Substitute (March 16, 2016)
  • K150825 — Collagen Dural Regeneration Matrix (November 20, 2015)