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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 the device name listed in this FDA 510(k) record. The listed applicant is Globus Medical, Inc.. It received FDA 510(k) clearance on 2024-12-06 under 510(k) 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. The listed applicant is Globus Medical, Inc.. The 510(k) number is K241260.

When did ACTIFY™ Unicondylar Knee System receive FDA 510(k) clearance?

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

Who is the listed applicant for ACTIFY™ Unicondylar Knee System?

The FDA 510(k) record lists Globus Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

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Other records listing Globus Medical, Inc. as applicant

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Related Devices (Code: HSX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus OrthopedicsK251771Cambridge Partial KneeSignature Orthopaedics Pty, Ltd.K251834Persona Partial KneeZimmer BiometK251618MOTO Partial Knee System ExtensionMedacta International S.A.K251453Arthrex iBalance Partial Knee SystemArthrex, Inc.K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.

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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