FDA 510(k) Application Details - K163156

Device Classification Name	More FDA Info for this Device
510(K) Number	K163156
Device Name	SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides
Applicant	Materialise NV Technologielaan 15 Leuven 3001 BE Other 510(k) Applications for this Company
Contact	Oliver Clemens Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PBF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/10/2016
Decision Date	01/18/2017
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