MPACT Extension
K-Number: K183582 · 2019-03-21
ApplicantMedacta International S.A.
Decision Date2019-03-21
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
MPACT Extension is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2019-03-21 under approval number K183582. 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 Extension?
MPACT Extension is a medical device that received FDA 510(k) clearance on 2019-03-21. It is manufactured by Medacta International S.A.. The 510(k) number is K183582.
When was MPACT Extension approved by the FDA?
MPACT Extension received FDA 510(k) clearance on 2019-03-21, under approval number K183582.
What company makes MPACT Extension?
MPACT Extension is manufactured by Medacta International S.A..
What is the FDA product code for MPACT Extension?
The FDA product code for MPACT Extension 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.