FDA 510(k)

Trident II Acetabular System

N.º K: K191358 · 2019-10-24

SolicitanteHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics

Fecha de decisión2019-10-24

Código de productoLPH

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del 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 2019-10-24 under 510(k) number K191358. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Trident II Acetabular System?

Trident II Acetabular System is a medical device that received FDA 510(k) clearance on 2019-10-24. The listed applicant is Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. The 510(k) number is K191358.

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

Trident II Acetabular System received FDA 510(k) clearance on 2019-10-24, under 510(k) number K191358.

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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Otros registros que enlistan a Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics como solicitante

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Dispositivos relacionados (Código: LPH)

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Fuente oficial

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