FDA 510(k) Application Details - K231585

Device Classification Name	More FDA Info for this Device
510(K) Number	K231585
Device Name	Vantage PSI System
Applicant	3D Systems, Inc. 5381 South Alkire Circle Littleton, CO 80127 US Other 510(k) Applications for this Company
Contact	Ashley Dawson Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OYK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/31/2023
Decision Date	06/30/2023
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