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510(k) K183321

Treace Medical Concepts (TMC) Plating System by Treace Medical Concepts, Inc. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 2019
Date Received
November 30, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Treace Medical Concepts, Inc.

  • K260361 — Treace Medical Concepts (TMC) Screw Fixation System (March 6, 2026)
  • K251135 — Treace Medical Concepts (TMC) Implant Fixation System (August 21, 2025)
  • 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)
  • K222564 — Treace Medical Concepts (TMC) Hammertoe Fixation System (November 15, 2022)

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  • K254054 — VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System (March 2, 2026)
  • K254249 — HKT Anatomical Locking Trauma System (February 27, 2026)
  • K252166 — RIB LINK™ Fixation System (February 26, 2026)
  • K253660 — KLS Martin Pure Pectus System (February 20, 2026)
  • K251732 — Wrist Fracture System (February 12, 2026)
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