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FDA 510(k)

Apex Revision Knee System

K-Number: K163332 · 2017-04-26

ApplicantOmnilife Science
Decision Date2017-04-26
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Apex Revision Knee System is a medical device manufactured by Omnilife Science. It received FDA 510(k) clearance on 2017-04-26 under approval number K163332. 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 Apex Revision Knee System?

Apex Revision Knee System is a medical device that received FDA 510(k) clearance on 2017-04-26. It is manufactured by Omnilife Science. The 510(k) number is K163332.

When was Apex Revision Knee System approved by the FDA?

Apex Revision Knee System received FDA 510(k) clearance on 2017-04-26, under approval number K163332.

What company makes Apex Revision Knee System?

Apex Revision Knee System is manufactured by Omnilife Science.

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

The FDA product code for Apex 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 NCT03153475 ATTUNE Revision System in the Revision Total Knee Arthroplasty Population ACTIVE_NOT_RECRUITING NCT04984291 Zimmer Biomet Shoulder Arthroplasty PMCF RECRUITING NCT01480440 Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder System ACTIVE_NOT_RECRUITING

Other Devices by Omnilife Science

K172467OMNI ARC Anteverted Neck Hip Stem K171156OMNI Anseris Hip Stem K201611Apex Knee System

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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