Knee+— 510(k) K243975

Substantially Equivalent

Pixee Medical

FDA 510(k) clearance K243975 for Knee+, Substantially Equivalent on 2025-03-20. 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: 2024-12-23
Decision date: 2025-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Besançon, FR

Download summary PDF View on FDA.gov ↗

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