FDA 510(k)

DePuy Synthes Static Staples

Número K: K180544 · 2018-07-24

Data da decisão2018-07-24

Código do produtoJDR

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

DePuy Synthes Static Staples 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 2018-07-24 under 510(k) number K180544. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the DePuy Synthes Static Staples?

DePuy Synthes Static Staples is a medical device that received FDA 510(k) clearance on 2018-07-24. The listed applicant is Synthes (USA) Products, LLC. The 510(k) number is K180544.

When did DePuy Synthes Static Staples receive FDA 510(k) clearance?

DePuy Synthes Static Staples received FDA 510(k) clearance on 2018-07-24, under 510(k) number K180544.

Who is the listed applicant for DePuy Synthes Static Staples?

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 Static Staples?

The FDA product code for DePuy Synthes Static Staples is JDR.

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