UNiD Spine Analyzer— 510(k) K251629

Name: FDA 510(k) clearance K251629
Creator: U.S. Food and Drug Administration
Published: 2025-08-07

Substantially Equivalent

Medicrea International S.A.S. (Medtronic)

FDA 510(k) clearance K251629 for UNiD Spine Analyzer, Substantially Equivalent on 2025-08-07. 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: 2025-05-28
Decision date: 2025-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
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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K261289 — UNiD Spine Analyzer (SW3002)2026-05-15
K253577 — IB3D PL Spinal System (A24000000 / IB3D Universal Implant Inserter)2025-12-19
K241164 — IB3D PL Spinal System2024-09-06

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