FDA 510(k)

Mpact 3D Metal Implants Extension – DMLS Technology

Número K: K251043 · 2026-01-28

Data da decisão2026-01-28

Código do produtoLPH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Mpact 3D Metal Implants Extension – DMLS Technology is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International S.A.. It received FDA 510(k) clearance on 2026-01-28 under 510(k) number K251043. 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 Mpact 3D Metal Implants Extension – DMLS Technology?

Mpact 3D Metal Implants Extension – DMLS Technology is a medical device that received FDA 510(k) clearance on 2026-01-28. The listed applicant is Medacta International S.A.. The 510(k) number is K251043.

When did Mpact 3D Metal Implants Extension – DMLS Technology receive FDA 510(k) clearance?

Mpact 3D Metal Implants Extension – DMLS Technology received FDA 510(k) clearance on 2026-01-28, under 510(k) number K251043.

Who is the listed applicant for Mpact 3D Metal Implants Extension – DMLS Technology?

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

What is the FDA product code for Mpact 3D Metal Implants Extension – DMLS Technology?

The FDA product code for Mpact 3D Metal Implants Extension – DMLS Technology is LPH.

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Fonte oficial

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