FDA 510(k)

Pantheon Proximal Femur Reconstruction (PFR) System

Número K: K241059 · 2025-01-13

Data da decisão2025-01-13

Código do produtoLPH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Pantheon Proximal Femur Reconstruction (PFR) System is the device name listed in this FDA 510(k) record. The listed applicant is Adler Ortho S.P.A. It received FDA 510(k) clearance on 2025-01-13 under 510(k) number K241059. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Pantheon Proximal Femur Reconstruction (PFR) System?

Pantheon Proximal Femur Reconstruction (PFR) System is a medical device that received FDA 510(k) clearance on 2025-01-13. The listed applicant is Adler Ortho S.P.A. The 510(k) number is K241059.

When did Pantheon Proximal Femur Reconstruction (PFR) System receive FDA 510(k) clearance?

Pantheon Proximal Femur Reconstruction (PFR) System received FDA 510(k) clearance on 2025-01-13, under 510(k) number K241059.

Who is the listed applicant for Pantheon Proximal Femur Reconstruction (PFR) System?

The FDA 510(k) record lists Adler Ortho S.P.A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pantheon Proximal Femur Reconstruction (PFR) System?

The FDA product code for Pantheon Proximal Femur Reconstruction (PFR) System is LPH.

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Fonte oficial

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