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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Treace Medical Concepts. It received FDA 510(k) clearance on 2023-08-28 under 510(k) 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. The listed applicant is Treace Medical Concepts. The 510(k) number is K232387.

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

Treace Medical Concepts (TMC) Compression Implant System received FDA 510(k) clearance on 2023-08-28, under 510(k) number K232387.

Who is the listed applicant for Treace Medical Concepts (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 Treace Medical Concepts (TMC) Compression Implant System?

The FDA product code for Treace Medical Concepts (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 SystemK242415TMC Compression Implant SystemK240173Treace Medical Systems (TMC) Plating 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 ConceptsK242415TMC Compression Implant SystemTreace Medical Concepts

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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