FDA 510(k) Application Details - K231834

Device Classification Name	Plate, Cranioplasty, Preformed, Alterable   More FDA Info for this Device
510(K) Number	K231834
Device Name	Plate, Cranioplasty, Preformed, Alterable
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	882.5320   More FDA Info for this Regulation Number
Classification Product Code	GWO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/22/2023
Decision Date	04/04/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review