FDA 510(k)

Sistema Interbody Acro Composites Interbody System

Número K: K230478 · 2023-10-19

Data da decisão2023-10-19

Código do produtoODP

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Acro Composites Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Acro Composites, LLC. It received FDA 510(k) clearance on 2023-10-19 under 510(k) number K230478. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Acro Composites Interbody System?

Acro Composites Interbody System is a medical device that received FDA 510(k) clearance on 2023-10-19. The listed applicant is Acro Composites, LLC. The 510(k) number is K230478.

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

Acro Composites Interbody System received FDA 510(k) clearance on 2023-10-19, under 510(k) number K230478.

Who is the listed applicant for Acro Composites Interbody System?

The FDA 510(k) record lists Acro Composites, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Acro Composites Interbody System?

The FDA product code for Acro Composites Interbody System is ODP.

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