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FDA 510(k)

ACTIFY™ Unicondylar Knee System

K-Number: K241260 · 2024-12-06

ApplicantGlobus Medical, Inc.
Decision Date2024-12-06
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACTIFY™ Unicondylar Knee System is a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2024-12-06 under approval number K241260. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACTIFY™ Unicondylar Knee System?

ACTIFY™ Unicondylar Knee System is a medical device that received FDA 510(k) clearance on 2024-12-06. It is manufactured by Globus Medical, Inc.. The 510(k) number is K241260.

When was ACTIFY™ Unicondylar Knee System approved by the FDA?

ACTIFY™ Unicondylar Knee System received FDA 510(k) clearance on 2024-12-06, under approval number K241260.

What company makes ACTIFY™ Unicondylar Knee System?

ACTIFY™ Unicondylar Knee System is manufactured by Globus Medical, Inc..

What is the FDA product code for ACTIFY™ Unicondylar Knee System?

The FDA product code for ACTIFY™ Unicondylar Knee System is HSX.

Other Devices by Globus Medical, Inc.

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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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