FDA 510(k)

UNiD Spine Analyzer (SW3002)

K-Number: K261289 · 2026-05-15

ApplicantMedicrea International S.A.S. (Medtronic)

Decision Date2026-05-15

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

UNiD Spine Analyzer (SW3002) is a medical device manufactured by Medicrea International S.A.S. (Medtronic). It received FDA 510(k) clearance on 2026-05-15 under approval number K261289. 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 (SW3002)?

UNiD Spine Analyzer (SW3002) is a medical device that received FDA 510(k) clearance on 2026-05-15. It is manufactured by Medicrea International S.A.S. (Medtronic). The 510(k) number is K261289.

When was UNiD Spine Analyzer (SW3002) approved by the FDA?

UNiD Spine Analyzer (SW3002) received FDA 510(k) clearance on 2026-05-15, under approval number K261289.

What company makes UNiD Spine Analyzer (SW3002)?

UNiD Spine Analyzer (SW3002) is manufactured by Medicrea International S.A.S. (Medtronic).

What is the FDA product code for UNiD Spine Analyzer (SW3002)?

The FDA product code for UNiD Spine Analyzer (SW3002) is QIH.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.