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FDA 510(k)

TMC Compression Implant System

K-Number: K243658 · 2024-12-26

ApplicantTreace Medical Concepts
Decision Date2024-12-26
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TMC Compression Implant System is a medical device manufactured by Treace Medical Concepts. It received FDA 510(k) clearance on 2024-12-26 under approval number K243658. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TMC Compression Implant System?

TMC Compression Implant System is a medical device that received FDA 510(k) clearance on 2024-12-26. It is manufactured by Treace Medical Concepts. The 510(k) number is K243658.

When was TMC Compression Implant System approved by the FDA?

TMC Compression Implant System received FDA 510(k) clearance on 2024-12-26, under approval number K243658.

What company makes TMC Compression Implant System?

TMC Compression Implant System is manufactured by Treace Medical Concepts.

What is the FDA product code for TMC Compression Implant System?

The FDA product code for TMC Compression Implant System is JDR.

Related Clinical Trials

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Related PubMed Literature

PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025) PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Treace Medical Concepts

K222645Treace Medical Concepts (TMC) Implant Fixation System K232387Treace Medical Concepts (TMC) Compression Implant System K242415TMC Compression Implant System K251135Treace Medical Concepts (TMC) Implant Fixation System

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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