IB3D ALIF
K-Number: K191134 · 2019-10-30
ApplicantMedicrea International SA
Decision Date2019-10-30
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
IB3D ALIF is a medical device manufactured by Medicrea International SA. It received FDA 510(k) clearance on 2019-10-30 under approval number K191134. 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 IB3D ALIF?
IB3D ALIF is a medical device that received FDA 510(k) clearance on 2019-10-30. It is manufactured by Medicrea International SA. The 510(k) number is K191134.
When was IB3D ALIF approved by the FDA?
IB3D ALIF received FDA 510(k) clearance on 2019-10-30, under approval number K191134.
What company makes IB3D ALIF?
IB3D ALIF is manufactured by Medicrea International SA.
What is the FDA product code for IB3D ALIF?
The FDA product code for 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.