FDA 510(k)

DePuy 3D Additive TriFlange Acetabular Cup

Número K: K201348 · 2022-06-16

Data da decisão2022-06-16

Código do produtoLPH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

DePuy 3D Additive TriFlange Acetabular Cup is the device name listed in this FDA 510(k) record. The listed applicant is Depuy International, Ltd.. It received FDA 510(k) clearance on 2022-06-16 under 510(k) number K201348. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the DePuy 3D Additive TriFlange Acetabular Cup?

DePuy 3D Additive TriFlange Acetabular Cup is a medical device that received FDA 510(k) clearance on 2022-06-16. The listed applicant is Depuy International, Ltd.. The 510(k) number is K201348.

When did DePuy 3D Additive TriFlange Acetabular Cup receive FDA 510(k) clearance?

DePuy 3D Additive TriFlange Acetabular Cup received FDA 510(k) clearance on 2022-06-16, under 510(k) number K201348.

Who is the listed applicant for DePuy 3D Additive TriFlange Acetabular Cup?

The FDA 510(k) record lists Depuy International, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DePuy 3D Additive TriFlange Acetabular Cup?

The FDA product code for DePuy 3D Additive TriFlange Acetabular Cup is LPH.

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Fonte oficial

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