FDA 510(k)

Klassic HD® Hip System

Número K: K180929 · 2018-05-09

Data da decisão2018-05-09

Código do produtoLZO

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Klassic HD® Hip System 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 2018-05-09 under 510(k) number K180929. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Klassic HD® Hip System?

Klassic HD® Hip System is a medical device that received FDA 510(k) clearance on 2018-05-09. The listed applicant is Total Joint Orthopedics, Inc.. The 510(k) number is K180929.

When did Klassic HD® Hip System receive FDA 510(k) clearance?

Klassic HD® Hip System received FDA 510(k) clearance on 2018-05-09, under 510(k) number K180929.

Who is the listed applicant for Klassic HD® Hip System?

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® Hip System?

The FDA product code for Klassic HD® Hip System is LZO.

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Outros registros que listam Total Joint Orthopedics, Inc. como candidato(a)

K261734Klassic Infection Spacer System K220483Platform® Acetabular System K211877Klassic Knee System K211602Klassic Knee System K202740Klassic Knee System Tibial Inserts, PS-Max K183596Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic Knee Tibial Insert, PS-Post, E-Link Poly

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Dispositivos Relacionados (Código: LZO)

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Fonte oficial

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