FDA 510(k) Application Details - K243975

Device Classification Name	More FDA Info for this Device
510(K) Number	K243975
Device Name	Knee+
Applicant	Pixee Medical 18 rue Alain Savary Besancon 25000 FR Other 510(k) Applications for this Company
Contact	Franτois Beaumont Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SBF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/2024
Decision Date	03/20/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review