FDA 510(k)

Summit Patella Plating System

Número K: K203408 · 2021-07-30

Data da decisão2021-07-30

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Summit Patella Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Endeavor Orthopaedics, LLC. It received FDA 510(k) clearance on 2021-07-30 under 510(k) number K203408. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Summit Patella Plating System?

Summit Patella Plating System is a medical device that received FDA 510(k) clearance on 2021-07-30. The listed applicant is Endeavor Orthopaedics, LLC. The 510(k) number is K203408.

When did Summit Patella Plating System receive FDA 510(k) clearance?

Summit Patella Plating System received FDA 510(k) clearance on 2021-07-30, under 510(k) number K203408.

Who is the listed applicant for Summit Patella Plating System?

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

What is the FDA product code for Summit Patella Plating System?

The FDA product code for Summit Patella Plating System is HRS.

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