FDA 510(k)

EVOLUTION NitrX Medial-Pivot Knee

K-Number: K182251 · 2019-05-16

Decision Date2019-05-16

Product CodeJWH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

EVOLUTION NitrX Medial-Pivot Knee is a medical device manufactured by Mircoport Orthopedics, Inc.. It received FDA 510(k) clearance on 2019-05-16 under approval number K182251. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Mircoport Orthopedics, Inc.. The 510(k) number is K182251.

When was EVOLUTION NitrX Medial-Pivot Knee approved by the FDA?

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

What company makes EVOLUTION NitrX Medial-Pivot Knee?

EVOLUTION NitrX Medial-Pivot Knee is manufactured by Mircoport Orthopedics, Inc..

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

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

Related Clinical Trials

NCT04103502 In Vivo Kinematics for Subjects Having a MicroPort Medial Pivot or DePuy Attune PCR TKA WITHDRAWN

Related Devices (Code: JWH)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.