FDA 510(k) Application Details - K233408

Device Classification Name	More FDA Info for this Device
510(K) Number	K233408
Device Name	Materialise Shoulder SystemÖ, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
Applicant	Materialise N.V. Technologielaan 15 Leuven 3001 BE Other 510(k) Applications for this Company
Contact	Giulia Girola 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	10/06/2023
Decision Date	11/09/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review