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Treace Medical Concepts, Inc.

FDA 510(k) & PMA Approved Devices — 14 products

Total Devices14
Categories2
Latest FDA decision2026-03-06

SEC Filings: 1 filings on record. Latest: 10-Q (2026-08-07). View on SEC EDGAR →

TypeNumberDevice NameCodeDateActions
510(k) K260361 Treace Medical Concepts (TMC) Screw Fixation SystemHWC2026-03-06 View
510(k) K242671 Treace Medical Concepts (TMC) Screw Fixation SystemHWC2024-10-04 View
510(k) K240173 Treace Medical Systems (TMC) Plating SystemHRS2024-02-22 View
510(k) K221181 Treace Medical Concepts (TMC) Plating SystemHRS2023-01-05 View
510(k) K222564 Treace Medical Concepts (TMC) Hammertoe Fixation SystemHWC2022-11-15 View
510(k) K220136 Treace Medical Concepts (TMC) Plating SystemHRS2022-02-16 View
510(k) K213036 Treace Medical Concepts (TMC) Screw Fixation SystemHWC2021-10-21 View
510(k) K200961 Treace Medical Concepts (TMC) Plating SystemHRS2020-05-08 View
510(k) K192504 Treace Medical Concepts (TMC) Plating SystemHRS2019-10-30 View
510(k) K183363 Treace Medical Concepts (TMC) Snap-Off Screw SystemHWC2019-06-13 View
510(k) K183321 Treace Medical Concepts (TMC) Plating SystemHRS2019-01-25 View
510(k) K173930 PYTHON Plate Trial InstrumentsHRS2018-03-19 View
510(k) K172617 Treace Medical Concepts (TMC) Compression Screw SystemHWC2017-10-25 View
510(k) K153531 Treace Medical Concepts (TMC) Plating SystemHRS2016-01-07 View
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