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510(k) K241906

BioBrace® Reinforced Implant by Conmed Corporation — Product Code OWW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2024
Date Received
July 1, 2024
Clearance Type
Special
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.

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Other clearances for product code OWW

  • K251655 — VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1) (July 18, 2025)
  • K250021 — Rotium (February 27, 2025)
  • K242187 — BioBrace® (November 27, 2024)
  • K240817 — VersaWrap (June 14, 2024)
  • K222220 — SpinMedix Absorbable Fibrous Membrane (July 6, 2023)
  • K230316 — FlexBand; FlexPatch; FlexBand Plus (May 26, 2023)
  • K203267 — The BioBrace Implant (April 30, 2021)
  • K160364 — VersaWrap Tendon Protector (June 10, 2016)
  • K121216 — STR GRAFT (November 21, 2012)