UNiD IB3D ALIF
K-Number: K200316 · 2020-10-30
ApplicantMedicrea International SA
Decision Date2020-10-30
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
UNiD IB3D ALIF is a medical device manufactured by Medicrea International SA. It received FDA 510(k) clearance on 2020-10-30 under approval number K200316. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the UNiD IB3D ALIF?
UNiD IB3D ALIF is a medical device that received FDA 510(k) clearance on 2020-10-30. It is manufactured by Medicrea International SA. The 510(k) number is K200316.
When was UNiD IB3D ALIF approved by the FDA?
UNiD IB3D ALIF received FDA 510(k) clearance on 2020-10-30, under approval number K200316.
What company makes UNiD IB3D ALIF?
UNiD IB3D ALIF is manufactured by Medicrea International SA.
What is the FDA product code for UNiD IB3D ALIF?
The FDA product code for UNiD IB3D ALIF is MAX.
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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.