FDA 510(k)

Calibrate CCX Interbody System

Número K: K232504 · 2023-10-13

Data da decisão2023-10-13

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Calibrate CCX Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2023-10-13 under 510(k) number K232504. 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 Calibrate CCX Interbody System?

Calibrate CCX Interbody System is a medical device that received FDA 510(k) clearance on 2023-10-13. The listed applicant is Alphatec Spine, Inc.. The 510(k) number is K232504.

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

Calibrate CCX Interbody System received FDA 510(k) clearance on 2023-10-13, under 510(k) number K232504.

Who is the listed applicant for Calibrate CCX Interbody System?

The FDA 510(k) record lists Alphatec Spine, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Calibrate CCX Interbody System?

The FDA product code for Calibrate CCX Interbody System is MAX.

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Dispositivos Relacionados (Código: MAX)

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Fonte oficial

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