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

Name: FDA 510(k) clearance K261289
Creator: U.S. Food and Drug Administration
Published: 2026-05-15

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). Device class: 2.

Clearance details

Applicant: Medicrea International S.A.S. (Medtronic)
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2026-04-20
Decision date: 2026-05-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Rillieux-La-Pape, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code QIH

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K261795 — Quicktome Software Suite2026-09-10
K251417 — ReVISION 22026-09-09
K260525 — NextMR Spine2026-09-04
K260811 — Heartvue.Proton2026-08-26

More clearances from Medicrea International S.A.S. (Medtronic)

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K253577 — IB3D PL Spinal System (A24000000 / IB3D Universal Implant Inserter)2025-12-19
K251629 — UNiD Spine Analyzer2025-08-07
K241164 — IB3D PL Spinal System2024-09-06

Data sourced from openFDA. This site is unofficial and independent of the FDA.