MiniMAX
K-Number: K192352 · 2019-09-27
ApplicantMedacta International S.A.
Decision Date2019-09-27
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
MiniMAX is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2019-09-27 under approval number K192352. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the MiniMAX?
MiniMAX is a medical device that received FDA 510(k) clearance on 2019-09-27. It is manufactured by Medacta International S.A.. The 510(k) number is K192352.
When was MiniMAX approved by the FDA?
MiniMAX received FDA 510(k) clearance on 2019-09-27, under approval number K192352.
What company makes MiniMAX?
MiniMAX is manufactured by Medacta International S.A..
What is the FDA product code for MiniMAX?
The FDA product code for MiniMAX is LZO.
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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.