FDA 510(k)

ACTIFY 3D Total Knee System, ACTIFY Total Knee System

K-Number: K240669 · 2024-06-20

Decision Date2024-06-20

Product CodeJWH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

ACTIFY 3D Total Knee System, ACTIFY Total Knee System is a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2024-06-20 under approval number K240669. 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 ACTIFY 3D Total Knee System, ACTIFY Total Knee System?

ACTIFY 3D Total Knee System, ACTIFY Total Knee System is a medical device that received FDA 510(k) clearance on 2024-06-20. It is manufactured by Globus Medical, Inc.. The 510(k) number is K240669.

When was ACTIFY 3D Total Knee System, ACTIFY Total Knee System approved by the FDA?

ACTIFY 3D Total Knee System, ACTIFY Total Knee System received FDA 510(k) clearance on 2024-06-20, under approval number K240669.

What company makes ACTIFY 3D Total Knee System, ACTIFY Total Knee System?

ACTIFY 3D Total Knee System, ACTIFY Total Knee System is manufactured by Globus Medical, Inc..

What is the FDA product code for ACTIFY 3D Total Knee System, ACTIFY Total Knee System?

The FDA product code for ACTIFY 3D Total Knee System, ACTIFY Total Knee System is JWH.

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Related PubMed Literature

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Other Devices by Globus Medical, Inc.

K161379ELSA Spacers K161591QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments K160597INDEPENDENCE MIS Spacers K161223TransContinental® M Spacers and InterContinental® Plate-Spacers K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer K151665SUSTAIN Additional Implants

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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.