FDA 510(k)

Z1 Hip System

Número K: K233476 · 2024-02-08

Data da decisão2024-02-08

Código do produtoLZO

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Z1 Hip System is the device name listed in this FDA 510(k) record. The listed applicant is Orchard Medical Development. It received FDA 510(k) clearance on 2024-02-08 under 510(k) number K233476. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Z1 Hip System?

Z1 Hip System is a medical device that received FDA 510(k) clearance on 2024-02-08. The listed applicant is Orchard Medical Development. The 510(k) number is K233476.

When did Z1 Hip System receive FDA 510(k) clearance?

Z1 Hip System received FDA 510(k) clearance on 2024-02-08, under 510(k) number K233476.

Who is the listed applicant for Z1 Hip System?

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

What is the FDA product code for Z1 Hip System?

The FDA product code for Z1 Hip System is LZO.

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Fonte oficial

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