FDA 510(k) clearance · back to tracker
UNiD Spine Analyzer (SW3002)
Medicrea International S.A.S. (Medtronic) cleared K261289 on 2026-05-15, decision: substantially equivalent
K-number
K261289
Sponsor
Medicrea International S.A.S. (Medtronic)
Device
UNiD Spine Analyzer (SW3002)
Class
Class II
Decision
Substantially Equivalent
Decision date
2026-05-15
Product code
QIH
Advisory committee
Radiology
Medical specialty
Radiology
Regulation number
892.2050
Official FDA record
Open K261289on accessdata.fda.gov →
FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.
openFDA JSON
Raw record →
Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.
Use this as a predicate
Drop K261289 into Compass and start a substantial-equivalence draft.
Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.
Try the sandboxSource
Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.