Mpact 3D Metal Augments II
K-Number: K242232 · 2025-04-23
ApplicantMedacta International S.A.
Decision Date2025-04-23
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Mpact 3D Metal Augments II is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2025-04-23 under approval number K242232. 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 Augments II?
Mpact 3D Metal Augments II is a medical device that received FDA 510(k) clearance on 2025-04-23. It is manufactured by Medacta International S.A.. The 510(k) number is K242232.
When was Mpact 3D Metal Augments II approved by the FDA?
Mpact 3D Metal Augments II received FDA 510(k) clearance on 2025-04-23, under approval number K242232.
What company makes Mpact 3D Metal Augments II?
Mpact 3D Metal Augments II is manufactured by Medacta International S.A..
What is the FDA product code for Mpact 3D Metal Augments II?
The FDA product code for Mpact 3D Metal Augments II 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.