FDA 510(k)

ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)

Número K: K262251 · 2026-07-31

Data da decisão2026-07-31

Código do produtoJWH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert) 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 2026-07-31 under 510(k) number K262251. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)?

ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert) is a medical device that received FDA 510(k) clearance on 2026-07-31. The listed applicant is Globus Medical, Inc.. The 510(k) number is K262251.

When did ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert) receive FDA 510(k) clearance?

ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert) received FDA 510(k) clearance on 2026-07-31, under 510(k) number K262251.

Who is the listed applicant for ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)?

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™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)?

The FDA product code for ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert) is JWH.

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Fonte oficial

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