FDA 510(k)

FOCUS Interbody System

Número K: K221172 · 2022-10-14

Data da decisão2022-10-14

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

FOCUS Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Oc Medical Devices. It received FDA 510(k) clearance on 2022-10-14 under 510(k) number K221172. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the FOCUS Interbody System?

FOCUS Interbody System is a medical device that received FDA 510(k) clearance on 2022-10-14. The listed applicant is Oc Medical Devices. The 510(k) number is K221172.

When did FOCUS Interbody System receive FDA 510(k) clearance?

FOCUS Interbody System received FDA 510(k) clearance on 2022-10-14, under 510(k) number K221172.

Who is the listed applicant for FOCUS Interbody System?

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

What is the FDA product code for FOCUS Interbody System?

The FDA product code for FOCUS Interbody System is MAX.

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Fonte oficial

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