FDA 510(k)

Mpact® 3D Metal Implants and Augments 3D Metal

K-Number: K171966 · 2018-03-27

Decision Date2018-03-27

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Mpact® 3D Metal Implants and Augments 3D Metal is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2018-03-27 under approval number K171966. 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 and Augments 3D Metal?

Mpact® 3D Metal Implants and Augments 3D Metal is a medical device that received FDA 510(k) clearance on 2018-03-27. It is manufactured by Medacta International S.A.. The 510(k) number is K171966.

When was Mpact® 3D Metal Implants and Augments 3D Metal approved by the FDA?

Mpact® 3D Metal Implants and Augments 3D Metal received FDA 510(k) clearance on 2018-03-27, under approval number K171966.

What company makes Mpact® 3D Metal Implants and Augments 3D Metal?

Mpact® 3D Metal Implants and Augments 3D Metal is manufactured by Medacta International S.A..

What is the FDA product code for Mpact® 3D Metal Implants and Augments 3D Metal?

The FDA product code for Mpact® 3D Metal Implants and Augments 3D Metal is LPH.

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Official Source

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