Treace Medical Concepts (TMC) Compression Implant System
K-Number: K232387 · 2023-08-28
ApplicantTreace Medical Concepts
Decision Date2023-08-28
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Treace Medical Concepts (TMC) Compression Implant System is a medical device manufactured by Treace Medical Concepts. It received FDA 510(k) clearance on 2023-08-28 under approval number K232387. 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 Treace Medical Concepts (TMC) Compression Implant System?
Treace Medical Concepts (TMC) Compression Implant System is a medical device that received FDA 510(k) clearance on 2023-08-28. It is manufactured by Treace Medical Concepts. The 510(k) number is K232387.
When was Treace Medical Concepts (TMC) Compression Implant System approved by the FDA?
Treace Medical Concepts (TMC) Compression Implant System received FDA 510(k) clearance on 2023-08-28, under approval number K232387.
What company makes Treace Medical Concepts (TMC) Compression Implant System?
Treace Medical Concepts (TMC) Compression Implant System is manufactured by Treace Medical Concepts.
What is the FDA product code for Treace Medical Concepts (TMC) Compression Implant System?
The FDA product code for Treace Medical Concepts (TMC) Compression Implant System is JDR.
Related Clinical Trials
NCT01143558
Searching for Persistence of Infection in Lyme Disease
COMPLETED
NCT07137455
EDEN Intracardiac Electrogram Recording and Classifying System
ENROLLING_BY_INVITATION
NCT01174108
Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells
RECRUITING
NCT03280862
DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS
COMPLETED
NCT05701917
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
RECRUITING
NCT05391828
Persona MC vs PS RCT With ROSA
RECRUITING
Related PubMed Literature
PMID: 41879133
Medical Device Regulation - Who Does the FDA Serve?
The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)
PMID: 40775988
B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation.
Studies in health technology and informatics (2025)
PMID: 39977258
Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table.
European heart journal (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)
Other Devices by Treace Medical Concepts
Related Devices (Code: JDR)
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.