FDA 510(k)

UTS Stem

Número K: K172251 · 2017-10-24

Data da decisão2017-10-24

Código do produtoLPH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

UTS Stem is the device name listed in this FDA 510(k) record. The listed applicant is United Orthopedic Corporation. It received FDA 510(k) clearance on 2017-10-24 under 510(k) number K172251. 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 UTS Stem?

UTS Stem is a medical device that received FDA 510(k) clearance on 2017-10-24. The listed applicant is United Orthopedic Corporation. The 510(k) number is K172251.

When did UTS Stem receive FDA 510(k) clearance?

UTS Stem received FDA 510(k) clearance on 2017-10-24, under 510(k) number K172251.

Who is the listed applicant for UTS Stem?

The FDA 510(k) record lists United Orthopedic Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UTS Stem?

The FDA product code for UTS Stem is LPH.

Outros registros que listam United Orthopedic Corporation como candidato(a)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

K253948Momentum Acetabular Cup System K252725Stem Extension Line (U2 Total Knee System—PSA Type)K252303Stem Extension Line (USTAR II System)K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella K242315Resolve Modular Revision Hip Stem K243466Conformity Stem Extension Line, #0

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Fonte oficial

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