FDA 510(k)

Sistema 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) SIGMA

N.º K: K233980 · 2024-03-21

Fecha de decisión2024-03-21

Código de productoKRO

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System 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 2024-03-21 under 510(k) number K233980. 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 Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System?

ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System is a medical device that received FDA 510(k) clearance on 2024-03-21. The listed applicant is Depuy Ireland UC. The 510(k) number is K233980.

When did ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System receive FDA 510(k) clearance?

ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System received FDA 510(k) clearance on 2024-03-21, under 510(k) number K233980.

Who is the listed applicant for ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System?

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 Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System?

The FDA product code for ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System 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)

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Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.