FDA 510(k)

Rodilla de Bisagra Revision ATTUNE™

N.º K: K242871 · 2024-11-21

Fecha de decisión2024-11-21

Código de productoKRO

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

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Otros registros que enlistan a Depuy Ireland UC como solicitante

K260480VELYS™ Robotic-Assisted Solution K261458Sistema de Rodilla Total ATTUNE; Sistema de Rodilla de Cemento Libre ATTUNE K260536Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement K253624INHANCE™ Reverse Shoulder System K253551VELYS™ Hip Navigation K253197Sistema de Rodilla Total ATTUNE™; Manguito de Revisión Sleeve LPS™ de Adaptadores Femorales

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Dispositivos relacionados (Código: 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.K233980Sistema de Rodilla Total ATTUNE, Sistema de Rodilla de Cemento Libre ATTUNE, Sistema de Preservación de Miembro LPS, Sistema de Rodilla Parcial de Alto Rendimiento (HP) SIGMADepuy Ireland UC

Fuente oficial

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