FDA 510(k)

Treace Medical Concepts (TMC) Plating System

N.º K: K220136 · 2022-02-16

SolicitanteTreace Medical Concepts, Inc.

Fecha de decisión2022-02-16

Código de productoHRS

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Treace Medical Concepts (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 2022-02-16 under 510(k) number K220136. 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 Concepts (TMC) Plating System?

Treace Medical Concepts (TMC) Plating System is a medical device that received FDA 510(k) clearance on 2022-02-16. The listed applicant is Treace Medical Concepts, Inc.. The 510(k) number is K220136.

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

Treace Medical Concepts (TMC) Plating System received FDA 510(k) clearance on 2022-02-16, under 510(k) number K220136.

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

The FDA product code for Treace Medical Concepts (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 K240173Treace Medical Systems (TMC) Plating System K221181Treace Medical Concepts (TMC) Plating System K222564Treace Medical Concepts (TMC) Hammertoe Fixation 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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