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510(k) K243302

3DMatrix DynaFlex (DynaFlex) by Printbio, Inc. — Product Code OXF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2025
Date Received
October 18, 2024
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.

  • K232602 — 3DMatrix Surgical Mesh (May 23, 2024)

Other clearances for product code OXF

  • K251224 — Restrata Soft Tissue Reinforcement (STR) (June 20, 2025)
  • K232602 — 3DMatrix Surgical Mesh (May 23, 2024)
  • 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)