Knee+— 510(k) K220104

Substantially Equivalent

Pixee Medical

FDA 510(k) clearance K220104 for Knee+, Substantially Equivalent on 2022-09-01. Applicant: Pixee Medical. Device class: 2.

Clearance details

Applicant: Pixee Medical
Product code: Code SBF
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2022-01-12
Decision date: 2022-09-01
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
K253805 — Knee+2026-04-24
K252847 — NextAR Hip Platform2026-01-09
K251639 — xvision Spine system2025-10-03
K252054 — SpineAR SNAP (SyncAR Spine)2025-09-29

More clearances from Pixee Medical

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