FDA 510(k)

Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS

Número K: K231233 · 2023-05-26

Data da decisão2023-05-26

Código do produtoJWH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS is the device name listed in this FDA 510(k) record. The listed applicant is Conformis, Inc.. It received FDA 510(k) clearance on 2023-05-26 under 510(k) number K231233. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS?

Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS is a medical device that received FDA 510(k) clearance on 2023-05-26. The listed applicant is Conformis, Inc.. The 510(k) number is K231233.

When did Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS receive FDA 510(k) clearance?

Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS received FDA 510(k) clearance on 2023-05-26, under 510(k) number K231233.

Who is the listed applicant for Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS?

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

What is the FDA product code for Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS?

The FDA product code for Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS is JWH.

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Fonte oficial

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