FDA 510(k) Application Details - K243509

Device Classification Name	More FDA Info for this Device
510(K) Number	K243509
Device Name	Archer PSI System
Applicant	3D-Side Rue AndrΘ Dumont 5 Mont-saint-Guibert 1435 BE Other 510(k) Applications for this Company
Contact	Florence AllΘ Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QHE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/12/2024
Decision Date	05/12/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review