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510(k) K203267

The BioBrace Implant by Biorez, Inc. — Product Code OWW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2021
Date Received
November 5, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
Device Class
Class II
Regulation Number
878.3300
Review Panel
OR
Submission Type

For reinforcement of soft tissue where weakness exists during tendon repair procedures.

Other clearances for product code OWW

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  • K250021 — Rotium (February 27, 2025)
  • K242187 — BioBrace® (November 27, 2024)
  • K241906 — BioBrace® Reinforced Implant (July 29, 2024)
  • K240817 — VersaWrap (June 14, 2024)
  • K222220 — SpinMedix Absorbable Fibrous Membrane (July 6, 2023)
  • K230316 — FlexBand; FlexPatch; FlexBand Plus (May 26, 2023)
  • K160364 — VersaWrap Tendon Protector (June 10, 2016)
  • K121216 — STR GRAFT (November 21, 2012)