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510(k) K222564

Treace Medical Concepts (TMC) Hammertoe Fixation System by Treace Medical Concepts, Inc. — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2022
Date Received
August 24, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Treace Medical Concepts, Inc.

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  • K243658 — TMC Compression Implant System (December 26, 2024)
  • K242671 — Treace Medical Concepts (TMC) Screw Fixation System (October 4, 2024)
  • K242415 — TMC Compression Implant System (September 6, 2024)
  • K240173 — Treace Medical Systems (TMC) Plating System (February 22, 2024)
  • K232387 — Treace Medical Concepts (TMC) Compression Implant System (August 28, 2023)
  • K221181 — Treace Medical Concepts (TMC) Plating System (January 5, 2023)
  • K222645 — Treace Medical Concepts (TMC) Implant Fixation System (November 21, 2022)
  • K220136 — Treace Medical Concepts (TMC) Plating System (February 16, 2022)

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