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FDA 510(k)

Apex Knee System

K-Number: K201611 · 2021-04-02

ApplicantOmnilife Science
Decision Date2021-04-02
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Apex Knee System is a medical device manufactured by Omnilife Science. It received FDA 510(k) clearance on 2021-04-02 under approval number K201611. 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 Knee System?

Apex Knee System is a medical device that received FDA 510(k) clearance on 2021-04-02. It is manufactured by Omnilife Science. The 510(k) number is K201611.

When was Apex Knee System approved by the FDA?

Apex Knee System received FDA 510(k) clearance on 2021-04-02, under approval number K201611.

What company makes Apex Knee System?

Apex Knee System is manufactured by Omnilife Science.

What is the FDA product code for Apex Knee System?

The FDA product code for Apex Knee System is JWH.

Other Devices by Omnilife Science

K172467OMNI ARC Anteverted Neck Hip Stem K171156OMNI Anseris Hip Stem K163332Apex Revision 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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