FDA 510(k)

Genou à charnière ATTUNE® Révision

Numéro K : K242871 · 2024-11-21

Date de décision2024-11-21

Code produitKRO

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

ATTUNE™ Revision Hinge Knee is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Ireland UC. It received FDA 510(k) clearance on 2024-11-21 under 510(k) number K242871. The device is classified under product code KRO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the ATTUNE™ Revision Hinge Knee?

ATTUNE™ Revision Hinge Knee is a medical device that received FDA 510(k) clearance on 2024-11-21. The listed applicant is Depuy Ireland UC. The 510(k) number is K242871.

When did ATTUNE™ Revision Hinge Knee receive FDA 510(k) clearance?

ATTUNE™ Revision Hinge Knee received FDA 510(k) clearance on 2024-11-21, under 510(k) number K242871.

Who is the listed applicant for ATTUNE™ Revision Hinge Knee?

The FDA 510(k) record lists Depuy Ireland UC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ATTUNE™ Revision Hinge Knee?

The FDA product code for ATTUNE™ Revision Hinge Knee is KRO.

Essais cliniques associés

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Autres dossiers indiquant Depuy Ireland UC en tant que demandeur

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Dispositifs connexes (Code : KRO)

K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge BumperHowmedica Osteonics Corp., Dba Stryker Orthopaedics K252303Stem Extension Line (USTAR II System)United Orthopedic Corporation K251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics K240043EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS™ Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial InseMicroport Orthopedics, Inc.K233980ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee SystemDepuy Ireland UC

Source officielle

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