Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Treace Medical Systems (TMC) Plating System

K-Number: K240173 · 2024-02-22

ApplicantTreace Medical Concepts, Inc.
Decision Date2024-02-22
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Treace Medical Systems (TMC) Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Treace Medical Concepts, Inc.. It received FDA 510(k) clearance on 2024-02-22 under 510(k) number K240173. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Treace Medical Systems (TMC) Plating System?

Treace Medical Systems (TMC) Plating System is a medical device that received FDA 510(k) clearance on 2024-02-22. The listed applicant is Treace Medical Concepts, Inc.. The 510(k) number is K240173.

When did Treace Medical Systems (TMC) Plating System receive FDA 510(k) clearance?

Treace Medical Systems (TMC) Plating System received FDA 510(k) clearance on 2024-02-22, under 510(k) number K240173.

Who is the listed applicant for Treace Medical Systems (TMC) Plating System?

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

What is the FDA product code for Treace Medical Systems (TMC) Plating System?

The FDA product code for Treace Medical Systems (TMC) Plating System is HRS.

Other records listing Treace Medical Concepts, Inc. 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 SystemK232387Treace Medical Concepts (TMC) Compression Implant System

View all 19 devices →

Related Devices (Code: HRS)

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.

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip TechnicsK261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.K261191Alians Elbow SNewclip TechnicsK261054RibPlate SystemStryker Leibinger GmbH & Co KG

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.

↑