Home / 510(k) Clearances / K132850

510(k) K132850

BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DM by Rti Surgical, Inc. — Product Code GXQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2014
Date Received
September 11, 2013
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 Rti Surgical, Inc.

  • K253145 — Pre-Sutured Tendon (October 22, 2025)
  • K241555 — Moldable Bone Void Filler and Moldable Bone Void Filler + CCC (February 21, 2025)
  • K230036 — Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadru (June 23, 2023)
  • K172343 — Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology (October 23, 2017)
  • K163673 — Fortilink™-C with TETRAfuse™ 3D Technology (May 23, 2017)
  • K142070 — FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS (October 27, 2014)

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)