FDA 510(k)

Comprehensive Vault Reconstruction System

Número K: K202232 · 2021-02-19

Data da decisão2021-02-19

Código do produtoPHX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Comprehensive Vault Reconstruction System is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Manufacturing Corp. It received FDA 510(k) clearance on 2021-02-19 under 510(k) number K202232. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Comprehensive Vault Reconstruction System?

Comprehensive Vault Reconstruction System is a medical device that received FDA 510(k) clearance on 2021-02-19. The listed applicant is Biomet Manufacturing Corp. The 510(k) number is K202232.

When did Comprehensive Vault Reconstruction System receive FDA 510(k) clearance?

Comprehensive Vault Reconstruction System received FDA 510(k) clearance on 2021-02-19, under 510(k) number K202232.

Who is the listed applicant for Comprehensive Vault Reconstruction System?

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

What is the FDA product code for Comprehensive Vault Reconstruction System?

The FDA product code for Comprehensive Vault Reconstruction System is PHX.

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Fonte oficial

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