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510(k) K242187

BioBrace® by Conmed Corporation — Product Code OWW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 2024
Date Received
July 25, 2024
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 by Conmed Corporation

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  • K252946 — BioBrace® Extra-Articular Ligament Augmentation Kit (October 15, 2025)
  • K251530 — CONMED Argo Knotless® Anchor (June 18, 2025)
  • K250395 — BioBrace ® RC Delivery System (April 7, 2025)
  • K244025 — Argo Knotless GENESYS Anchor (January 28, 2025)
  • K240127 — PlumeSafe X5 Smoke Management System (August 5, 2024)
  • K241906 — BioBrace® Reinforced Implant (July 29, 2024)
  • K240090 — Argo Knotless GENESYS Anchor (March 5, 2024)
  • K231732 — CleanSeal Advanced Bipolar Vessel Sealer Maryland (October 23, 2023)
  • K230239 — AirSeal iFS System; AirSeal dV Solution (September 20, 2023)

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)
  • 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)
  • K203267 — The BioBrace Implant (April 30, 2021)
  • K160364 — VersaWrap Tendon Protector (June 10, 2016)
  • K121216 — STR GRAFT (November 21, 2012)