UNiD Spine Analyzer (SW3002)— 510(k) K261289

Substantially Equivalent

Medicrea International S.A.S. (Medtronic)

FDA 510(k) clearance K261289 for UNiD Spine Analyzer (SW3002), Substantially Equivalent on 2026-05-15. Applicant: Medicrea International S.A.S. (Medtronic).

Clearance details

Applicant: Medicrea International S.A.S. (Medtronic)
Product code: Code QIH
Advisory panel: Radiology
Date received: 2026-04-20
Decision date: 2026-05-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Rillieux-La-Pape, FR

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