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FDA 510(k)

TMC Compression Implant System

K-Number: K242415 · 2024-09-06

ApplicantTreace Medical Concepts
Decision Date2024-09-06
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TMC Compression Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Treace Medical Concepts. It received FDA 510(k) clearance on 2024-09-06 under 510(k) number K242415. 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 2024-09-06. The listed applicant is Treace Medical Concepts. The 510(k) number is K242415.

When did TMC Compression Implant System receive FDA 510(k) clearance?

TMC Compression Implant System received FDA 510(k) clearance on 2024-09-06, under 510(k) number K242415.

Who is the listed applicant for TMC Compression Implant System?

The FDA 510(k) record lists Treace Medical Concepts as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Treace Medical Concepts as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260361Treace Medical Concepts (TMC) Screw Fixation SystemK251135Treace Medical Concepts (TMC) Implant Fixation SystemK243658TMC Compression Implant SystemK242671Treace Medical Concepts (TMC) Screw Fixation SystemK240173Treace Medical Systems (TMC) Plating SystemK232387Treace Medical Concepts (TMC) Compression Implant System

View all 19 devices →

Related Devices (Code: JDR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261121Megalodon Dynamic Compression SystemParagon 28, Inc.K250712Linkt Compression Staple SystemTrax SurgicalK243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LPK243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.K243658TMC Compression Implant SystemTreace Medical ConceptsK240212COGNiTiON™ Staple SystemOrtho Solutions UK , Ltd.

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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