UNiD Patient specific 3D printed TLIF cage
K-Number: K190092 · 2019-05-08
ApplicantMedicrea International SA
Decision Date2019-05-08
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
UNiD Patient specific 3D printed TLIF cage is a medical device manufactured by Medicrea International SA. It received FDA 510(k) clearance on 2019-05-08 under approval number K190092. 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 Patient specific 3D printed TLIF cage?
UNiD Patient specific 3D printed TLIF cage is a medical device that received FDA 510(k) clearance on 2019-05-08. It is manufactured by Medicrea International SA. The 510(k) number is K190092.
When was UNiD Patient specific 3D printed TLIF cage approved by the FDA?
UNiD Patient specific 3D printed TLIF cage received FDA 510(k) clearance on 2019-05-08, under approval number K190092.
What company makes UNiD Patient specific 3D printed TLIF cage?
UNiD Patient specific 3D printed TLIF cage is manufactured by Medicrea International SA.
What is the FDA product code for UNiD Patient specific 3D printed TLIF cage?
The FDA product code for UNiD Patient specific 3D printed TLIF cage 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.