FDA 510(k)

Extremity All Suture System

N.º K: K241695 · 2024-09-12

Fecha de decisión2024-09-12

Código de productoMBI

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Extremity All Suture System is the device name listed in this FDA 510(k) record. The listed applicant is Field Orthopaedics. It received FDA 510(k) clearance on 2024-09-12 under 510(k) number K241695. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Extremity All Suture System?

Extremity All Suture System is a medical device that received FDA 510(k) clearance on 2024-09-12. The listed applicant is Field Orthopaedics. The 510(k) number is K241695.

When did Extremity All Suture System receive FDA 510(k) clearance?

Extremity All Suture System received FDA 510(k) clearance on 2024-09-12, under 510(k) number K241695.

Who is the listed applicant for Extremity All Suture System?

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

What is the FDA product code for Extremity All Suture System?

The FDA product code for Extremity All Suture System is MBI.

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Fuente oficial

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