FDA 510(k)

Simparo Anchor Line Fixation System

Número K: K222574 · 2023-02-04

Data da decisão2023-02-04

Código do produtoMBI

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Simparo Anchor Line Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Simparo, Inc.. It received FDA 510(k) clearance on 2023-02-04 under 510(k) number K222574. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Simparo Anchor Line Fixation System?

Simparo Anchor Line Fixation System is a medical device that received FDA 510(k) clearance on 2023-02-04. The listed applicant is Simparo, Inc.. The 510(k) number is K222574.

When did Simparo Anchor Line Fixation System receive FDA 510(k) clearance?

Simparo Anchor Line Fixation System received FDA 510(k) clearance on 2023-02-04, under 510(k) number K222574.

Who is the listed applicant for Simparo Anchor Line Fixation System?

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

What is the FDA product code for Simparo Anchor Line Fixation System?

The FDA product code for Simparo Anchor Line Fixation System is MBI.

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Fonte oficial

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