FDA 510(k)

Treace Medical Systems (TMC) Plating System

N.º K: K240173 · 2024-02-22

SolicitanteTreace Medical Concepts, Inc.

Fecha de decisión2024-02-22

Código de productoHRS

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

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Otros registros que enlistan a Treace Medical Concepts, Inc. como solicitante

K262963TMC Implant Fixation System K260361Treace Medical Concepts (TMC) Screw Fixation System K242671Treace Medical Concepts (TMC) Screw Fixation System K221181Treace Medical Concepts (TMC) Plating System K222564Treace Medical Concepts (TMC) Hammertoe Fixation System K220136Treace Medical Concepts (TMC) Plating System

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Dispositivos relacionados (Código: HRS)

K261892ProRib Fixation SystemCosta Surgical, Inc.K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)Ortler Global Tibbi Gerecler Anonim Sirketi K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.

Fuente oficial

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