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510(k) K172603

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 2017
Date Received
August 30, 2017
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.

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  • K170300 — Restrata Wound Matrix (April 26, 2017)
  • K161278 — Cerafix Dura Substitute (August 8, 2016)
  • K153613 — Cerafix Dura Substitute (March 16, 2016)

Other clearances for product code GXQ

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  • 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)
  • 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)
  • K150825 — Collagen Dural Regeneration Matrix (November 20, 2015)