FDA 510(k)

ATTUNE™ Quadril de Revisão de Articulação

Número K: K242871 · 2024-11-21

Data da decisão2024-11-21

Código do produtoKRO

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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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Outros registros que listam Depuy Ireland UC como candidato(a)

K260480VELYS™ Robotic-Assisted Solution K261458ATTUNE Sistema de Quadril Total; ATTUNE Sistema de Quadril Cimentado K260536Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement K253624INHANCE™ Reverse Shoulder System K253551VELYS™ Hip Navigation K253197ATTUNE™ Sistema de Quadril Total; ATTUNE™ Mangueira de Revisão LPS™ Adaptadores Femorais

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Dispositivos Relacionados (Código: KRO)

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