FDA 510(k)

Trident® II Acetabular System

Número K: K171768 · 2017-10-02

RequerenteHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics

Data da decisão2017-10-02

Código do produtoLPH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Trident® II Acetabular System is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. It received FDA 510(k) clearance on 2017-10-02 under 510(k) number K171768. 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 Trident® II Acetabular System?

Trident® II Acetabular System is a medical device that received FDA 510(k) clearance on 2017-10-02. The listed applicant is Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. The 510(k) number is K171768.

When did Trident® II Acetabular System receive FDA 510(k) clearance?

Trident® II Acetabular System received FDA 510(k) clearance on 2017-10-02, under 510(k) number K171768.

Who is the listed applicant for Trident® II Acetabular System?

The FDA 510(k) record lists Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Trident® II Acetabular System?

The FDA product code for Trident® II Acetabular System is LPH.

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Outros registros que listam Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics como candidato(a)

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Fonte oficial

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