FDA 510(k)

DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System

N.º K: K210205 · 2021-03-26

Fecha de decisión2021-03-26

Código de productoHRS

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (USA) Products, LLC. It received FDA 510(k) clearance on 2021-03-26 under 510(k) number K210205. 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 DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System?

DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System is a medical device that received FDA 510(k) clearance on 2021-03-26. The listed applicant is Synthes (USA) Products, LLC. The 510(k) number is K210205.

When did DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System receive FDA 510(k) clearance?

DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System received FDA 510(k) clearance on 2021-03-26, under 510(k) number K210205.

Who is the listed applicant for DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System?

The FDA 510(k) record lists Synthes (USA) Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System?

The FDA product code for DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System is HRS.

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Fuente oficial

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