UNiD Spine Analyzer
K-Number: K251629 · 2025-08-07
Decision Date2025-08-07
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
UNiD Spine Analyzer is a medical device manufactured by Medicrea International S.A.S. (Medtronic). It received FDA 510(k) clearance on 2025-08-07 under approval number K251629. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the UNiD Spine Analyzer?
UNiD Spine Analyzer is a medical device that received FDA 510(k) clearance on 2025-08-07. It is manufactured by Medicrea International S.A.S. (Medtronic). The 510(k) number is K251629.
When was UNiD Spine Analyzer approved by the FDA?
UNiD Spine Analyzer received FDA 510(k) clearance on 2025-08-07, under approval number K251629.
What company makes UNiD Spine Analyzer?
UNiD Spine Analyzer is manufactured by Medicrea International S.A.S. (Medtronic).
What is the FDA product code for UNiD Spine Analyzer?
The FDA product code for UNiD Spine Analyzer is QIH.
Other Devices by Medicrea International S.A.S. (Medtronic)
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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.