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FDA 510(k)

Mpact 3D Metal Implants Extension – DMLS Technology

K-Number: K251043 · 2026-01-28

ApplicantMedacta International S.A.
Decision Date2026-01-28
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Mpact 3D Metal Implants Extension – DMLS Technology is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2026-01-28 under approval number K251043. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Medacta International S.A.. The 510(k) number is K251043.

When was Mpact 3D Metal Implants Extension – DMLS Technology approved by the FDA?

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

What company makes Mpact 3D Metal Implants Extension – DMLS Technology?

Mpact 3D Metal Implants Extension – DMLS Technology is manufactured by Medacta International S.A..

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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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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