FDA 510(k)

Mg-PSZ Ceramic Femoral Head

Número K: K220336 · 2022-09-30

Data da decisão2022-09-30

Código do produtoLPH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Mg-PSZ Ceramic Femoral Head is the device name listed in this FDA 510(k) record. The listed applicant is Theken Companies. It received FDA 510(k) clearance on 2022-09-30 under 510(k) number K220336. 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 Mg-PSZ Ceramic Femoral Head?

Mg-PSZ Ceramic Femoral Head is a medical device that received FDA 510(k) clearance on 2022-09-30. The listed applicant is Theken Companies. The 510(k) number is K220336.

When did Mg-PSZ Ceramic Femoral Head receive FDA 510(k) clearance?

Mg-PSZ Ceramic Femoral Head received FDA 510(k) clearance on 2022-09-30, under 510(k) number K220336.

Who is the listed applicant for Mg-PSZ Ceramic Femoral Head?

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

What is the FDA product code for Mg-PSZ Ceramic Femoral Head?

The FDA product code for Mg-PSZ Ceramic Femoral Head is LPH.

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Fonte oficial

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