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510(k) K232602

3DMatrix Surgical Mesh by Printbio, Inc. — Product Code OXF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2024
Date Received
August 28, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
Submission Type

For reinforcement of soft tissue where weakness exists in plastic and reconstructive surgery.

Other clearances by Printbio, Inc.

  • K243302 — 3DMatrix DynaFlex (DynaFlex) (May 21, 2025)

Other clearances for product code OXF

  • K251224 — Restrata Soft Tissue Reinforcement (STR) (June 20, 2025)
  • K243302 — 3DMatrix DynaFlex (DynaFlex) (May 21, 2025)
  • K222919 — GORE® ENFORM Biomaterial (December 19, 2022)
  • K173333 — GORE ENFORM Biomaterial (April 5, 2018)
  • K172545 — SERI Contour (September 22, 2017)
  • K163217 — GORE BIO-A Tissue Reinforcement (February 10, 2017)
  • K123128 — SERI SURGICAL SCAFFOLD (April 25, 2013)