FDA 510(k)

aprevo® TLIF-C Articulating System

Número K: K241019 · 2024-07-09

Data da decisão2024-07-09

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

aprevo® TLIF-C Articulating System is the device name listed in this FDA 510(k) record. The listed applicant is Carlsmed. It received FDA 510(k) clearance on 2024-07-09 under 510(k) number K241019. 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 aprevo® TLIF-C Articulating System?

aprevo® TLIF-C Articulating System is a medical device that received FDA 510(k) clearance on 2024-07-09. The listed applicant is Carlsmed. The 510(k) number is K241019.

When did aprevo® TLIF-C Articulating System receive FDA 510(k) clearance?

aprevo® TLIF-C Articulating System received FDA 510(k) clearance on 2024-07-09, under 510(k) number K241019.

Who is the listed applicant for aprevo® TLIF-C Articulating System?

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

What is the FDA product code for aprevo® TLIF-C Articulating System?

The FDA product code for aprevo® TLIF-C Articulating System is MAX.

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Fonte oficial

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