FDA 510(k)

Sistema de Interbody de PEEK Impresso em 3D

Número K: K240250 · 2024-09-17

RequerenteNvision Biomedical Technologies, Inc.

Data da decisão2024-09-17

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

3D Printed PEEK Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Nvision Biomedical Technologies, Inc.. It received FDA 510(k) clearance on 2024-09-17 under 510(k) number K240250. 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 3D Printed PEEK Interbody System?

3D Printed PEEK Interbody System is a medical device that received FDA 510(k) clearance on 2024-09-17. The listed applicant is Nvision Biomedical Technologies, Inc.. The 510(k) number is K240250.

When did 3D Printed PEEK Interbody System receive FDA 510(k) clearance?

3D Printed PEEK Interbody System received FDA 510(k) clearance on 2024-09-17, under 510(k) number K240250.

Who is the listed applicant for 3D Printed PEEK Interbody System?

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

What is the FDA product code for 3D Printed PEEK Interbody System?

The FDA product code for 3D Printed PEEK Interbody System is MAX.

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Fonte oficial

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