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510(k) K183363

Treace Medical Concepts (TMC) Snap-Off Screw System by Treace Medical Concepts, Inc. — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2019
Date Received
December 4, 2018
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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  • 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)
  • K222564 — Treace Medical Concepts (TMC) Hammertoe Fixation System (November 15, 2022)

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