FDA 510(k)

Stryker Orthopaedics Hip Devices Labeling Update

Número K: K243784 · 2025-02-06

RequerenteHowmedica Osteonics Corp., Dba Stryker Orthopaedics

Data da decisão2025-02-06

Código do produtoLPH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Stryker Orthopaedics Hip Devices Labeling Update is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp., Dba Stryker Orthopaedics. It received FDA 510(k) clearance on 2025-02-06 under 510(k) number K243784. 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 Stryker Orthopaedics Hip Devices Labeling Update?

Stryker Orthopaedics Hip Devices Labeling Update is a medical device that received FDA 510(k) clearance on 2025-02-06. The listed applicant is Howmedica Osteonics Corp., Dba Stryker Orthopaedics. The 510(k) number is K243784.

When did Stryker Orthopaedics Hip Devices Labeling Update receive FDA 510(k) clearance?

Stryker Orthopaedics Hip Devices Labeling Update received FDA 510(k) clearance on 2025-02-06, under 510(k) number K243784.

Who is the listed applicant for Stryker Orthopaedics Hip Devices Labeling Update?

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

What is the FDA product code for Stryker Orthopaedics Hip Devices Labeling Update?

The FDA product code for Stryker Orthopaedics Hip Devices Labeling Update is LPH.

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Fonte oficial

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