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510(k) K153690

PriMatrix Dermal Repair Scaffold by Tei Biosciences, Inc. — Product Code KGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 2016
Date Received
December 23, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wound Dressing With Animal-Derived Material(S)
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Tei Biosciences, Inc.

  • K162965 — SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction (February 16, 2017)
  • K131286 — PRIMATRIX DERMAL REPAIR SCAFFOLD (August 5, 2013)
  • K100261 — PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD (December 10, 2010)
  • K083898 — SURGIMEND (February 4, 2009)
  • K083440 — PRIMATRIX DERMAL REPAIR SCAFFOLD (December 12, 2008)
  • K071807 — ORTHOMEND SOFT TISSUE MATRIX (August 6, 2007)
  • K061407 — PRIMATRIX DERMAL REPAIR SCAFFOLD (June 29, 2006)
  • K060829 — COSMATRIX (May 17, 2006)
  • K060984 — XENFORM SOFT TISSUE REPAIR MATRIX (May 17, 2006)
  • K060989 — TISSUEMEND SOFT TISSUE REPAIR MATRIX (May 15, 2006)

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  • K252673 — LacertaMatrix (December 22, 2025)
  • K253339 — Theracor (December 22, 2025)
  • K250864 — MatriDerm pluS+ Bi-Layer (December 19, 2025)
  • K242100 — SurgiAid Collagen Wound Dressing (HA) (October 16, 2025)
  • K252001 — Collagen Wound Dressing (October 10, 2025)
  • K250397 — Helios Dermal Scaffold (August 15, 2025)
  • K251845 — Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus (July 16, 2025)