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FDA 510(k)

Persona Revision Knee System

K-Number: K181947 · 2018-10-25

ApplicantZimmer, Inc.
Decision Date2018-10-25
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Persona Revision Knee System is a medical device manufactured by Zimmer, Inc.. It received FDA 510(k) clearance on 2018-10-25 under approval number K181947. 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 Persona Revision Knee System?

Persona Revision Knee System is a medical device that received FDA 510(k) clearance on 2018-10-25. It is manufactured by Zimmer, Inc.. The 510(k) number is K181947.

When was Persona Revision Knee System approved by the FDA?

Persona Revision Knee System received FDA 510(k) clearance on 2018-10-25, under approval number K181947.

What company makes Persona Revision Knee System?

Persona Revision Knee System is manufactured by Zimmer, Inc..

What is the FDA product code for Persona Revision Knee System?

The FDA product code for Persona Revision Knee System is JWH.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT03073941 A Multicenter Prospective Randomized Control Study on Persona Total Knee System vs NexGen ACTIVE_NOT_RECRUITING NCT03153475 ATTUNE Revision System in the Revision Total Knee Arthroplasty Population ACTIVE_NOT_RECRUITING NCT06089291 Persona IQ Cohort Study ENROLLING_BY_INVITATION NCT04984291 Zimmer Biomet Shoulder Arthroplasty PMCF RECRUITING

Other Devices by Zimmer, Inc.

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Related Devices (Code: JWH)

K160515PS2 Knee SystemConsensus Orthopedics, Inc. K160771Destiknee Total Knee SystemMeril Healthcare Private Limited K160157LOSPA Modular Knee SystemCorentec Co., Ltd. K162273Materialise TKA Guide SystemMaterialise NV K162422Klassic Knee SystemTotal Joint Orthopedics, Inc. K161945EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm)Encore Medical L.P.

Official Source

View on FDA Database →

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

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