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510(k) K212943

SyntheCel Dura Repair by Synthes (USA) Products, LLC — Product Code GXQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 2022
Date Received
September 15, 2021
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

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  • K201578 — DePuy Synthes Variable Angle Locking Patella Plating System (September 9, 2020)
  • K201336 — DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails (September 3, 2020)
  • K191463 — DePuy Synthes Hammertoe Continuous Compression Implant (February 26, 2020)
  • K192655 — Depuy Synthes Maxillofacial Portfolio - MR Conditional (December 30, 2019)

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