Home / 510(k) Clearances / K251224

510(k) K251224

Restrata Soft Tissue Reinforcement (STR) by Acera Surgical, Inc. — Product Code OXF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2025
Date Received
April 21, 2025
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 Acera Surgical, Inc.

  • K223725 — Restrata® MiniMatrix (May 18, 2023)
  • K193583 — Restrata® (September 25, 2020)
  • K172603 — Cerafix Dura Substitute (November 27, 2017)
  • K170300 — Restrata Wound Matrix (April 26, 2017)
  • K161278 — Cerafix Dura Substitute (August 8, 2016)
  • K153613 — Cerafix Dura Substitute (March 16, 2016)

Other clearances for product code OXF

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