FDA 510(k)

EVOLUTION NitrX Medial-Pivot Knee

Número K: K182251 · 2019-05-16

Data da decisão2019-05-16

Código do produtoJWH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

EVOLUTION NitrX Medial-Pivot Knee is the device name listed in this FDA 510(k) record. The listed applicant is Mircoport Orthopedics, Inc.. It received FDA 510(k) clearance on 2019-05-16 under 510(k) number K182251. 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 EVOLUTION NitrX Medial-Pivot Knee?

EVOLUTION NitrX Medial-Pivot Knee is a medical device that received FDA 510(k) clearance on 2019-05-16. The listed applicant is Mircoport Orthopedics, Inc.. The 510(k) number is K182251.

When did EVOLUTION NitrX Medial-Pivot Knee receive FDA 510(k) clearance?

EVOLUTION NitrX Medial-Pivot Knee received FDA 510(k) clearance on 2019-05-16, under 510(k) number K182251.

Who is the listed applicant for EVOLUTION NitrX Medial-Pivot Knee?

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

What is the FDA product code for EVOLUTION NitrX Medial-Pivot Knee?

The FDA product code for EVOLUTION NitrX Medial-Pivot Knee is JWH.

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