FDA 510(k)

Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly

Número K: K173104 · 2017-10-27

Data da decisão2017-10-27

Código do produtoOQG

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly is the device name listed in this FDA 510(k) record. The listed applicant is Total Joint Orthopedics, Inc.. It received FDA 510(k) clearance on 2017-10-27 under 510(k) number K173104. The device is classified under product code OQG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly?

Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly is a medical device that received FDA 510(k) clearance on 2017-10-27. The listed applicant is Total Joint Orthopedics, Inc.. The 510(k) number is K173104.

When did Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly receive FDA 510(k) clearance?

Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly received FDA 510(k) clearance on 2017-10-27, under 510(k) number K173104.

Who is the listed applicant for Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly?

The FDA 510(k) record lists Total Joint Orthopedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly?

The FDA product code for Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly is OQG.

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Fonte oficial

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