FDA 510(k)

FusionFrame Ring Lock System

Número K: K200343 · 2020-09-14

Data da decisão2020-09-14

Código do produtoKTT

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

FusionFrame Ring Lock System is the device name listed in this FDA 510(k) record. The listed applicant is Glw Medical Innovation. It received FDA 510(k) clearance on 2020-09-14 under 510(k) number K200343. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the FusionFrame Ring Lock System?

FusionFrame Ring Lock System is a medical device that received FDA 510(k) clearance on 2020-09-14. The listed applicant is Glw Medical Innovation. The 510(k) number is K200343.

When did FusionFrame Ring Lock System receive FDA 510(k) clearance?

FusionFrame Ring Lock System received FDA 510(k) clearance on 2020-09-14, under 510(k) number K200343.

Who is the listed applicant for FusionFrame Ring Lock System?

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

What is the FDA product code for FusionFrame Ring Lock System?

The FDA product code for FusionFrame Ring Lock System is KTT.

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Fonte oficial

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