Knee+— 510(k) K253805

Substantially Equivalent

Pixee Medical S.A.S.

FDA 510(k) clearance K253805 for Knee+, Substantially Equivalent on 2026-04-24. Applicant: Pixee Medical S.A.S.. Device class: 2.

Clearance details

Applicant: Pixee Medical S.A.S.
Product code: Code SBF
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2025-11-28
Decision date: 2026-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Besançon, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code SBF

K261854 — xvision Spine system2026-07-31
K252847 — NextAR Hip Platform2026-01-09
K251639 — xvision Spine system2025-10-03
K252054 — SpineAR SNAP (SyncAR Spine)2025-09-29
K252530 — OptiVu Shoulder2025-09-10

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