FDA 510(k) Application Details - K170818

Device Classification Name	More FDA Info for this Device
510(K) Number	K170818
Device Name	Craniomaxillofacial Distraction System (CMFD)
Applicant	Synthes USA Products, LLC 1301 Goshen Parkway West Chester, PA 19380 US Other 510(k) Applications for this Company
Contact	Nicholas Fountoulakis Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PBJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/20/2017
Decision Date	12/07/2017
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