COMPANY
Treace Medical Concepts
Timeline
- FDA FDA 510(k) clearance: TMC Implant Fixation System — K262963, Sep 15, 2026. Applicant at approval: Treace Medical Concepts, Inc. source ↗
- FDA FDA 510(k) clearance: Treace Medical Concepts (TMC) Screw Fixation System — K260361, Mar 6, 2026. Applicant at approval: Treace Medical Concepts, Inc. source ↗
- Debt Debt financing: $175M (up to, as announced), announced Dec 18, 2025. Source: SEC filing. source ↗
- FDA FDA 510(k) clearance: Treace Medical Concepts (TMC) Implant Fixation System — K251135, Aug 21, 2025. Applicant at approval: Treace Medical Concepts. source ↗
- FDA FDA 510(k) clearance: TMC Compression Implant System — K243658, Dec 26, 2024. Applicant at approval: Treace Medical Concepts. source ↗
Funding
- Debt financing: $175M (up to, as announced), announced Dec 18, 2025. Source: SEC filing. source ↗
FDA records (last 2 years)
- FDA 510(k) clearance: TMC Implant Fixation System — K262963, Sep 15, 2026. Applicant at approval: Treace Medical Concepts, Inc. source ↗
- FDA 510(k) clearance: Treace Medical Concepts (TMC) Screw Fixation System — K260361, Mar 6, 2026. Applicant at approval: Treace Medical Concepts, Inc. source ↗
- FDA 510(k) clearance: Treace Medical Concepts (TMC) Implant Fixation System — K251135, Aug 21, 2025. Applicant at approval: Treace Medical Concepts. source ↗
- FDA 510(k) clearance: TMC Compression Implant System — K243658, Dec 26, 2024. Applicant at approval: Treace Medical Concepts. source ↗
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