FDA 510(k)

ATTUNE Sistema de Quadril Total, ATTUNE Sistema de Quadril Cimentado, LPS Sistema de Preservação de Miembro, Sigma Sistema de Performance (HP) de Quadril Parcial

Número K: K233980 · 2024-03-21

Data da decisão2024-03-21

Código do produtoKRO

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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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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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Fonte oficial

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