FDA 510(k)

Global Modular Replacement System

Número K: K233261 · 2023-12-08

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

Data da decisão2023-12-08

Código do produtoJDI

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Global Modular Replacement 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 2023-12-08 under 510(k) number K233261. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Global Modular Replacement System?

Global Modular Replacement System is a medical device that received FDA 510(k) clearance on 2023-12-08. The listed applicant is Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. The 510(k) number is K233261.

When did Global Modular Replacement System receive FDA 510(k) clearance?

Global Modular Replacement System received FDA 510(k) clearance on 2023-12-08, under 510(k) number K233261.

Who is the listed applicant for Global Modular Replacement 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 Global Modular Replacement System?

The FDA product code for Global Modular Replacement System is JDI.

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Fonte oficial

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