FDA 510(k) Application Details - K162864

Device Classification Name	Methyl Methacrylate For Cranioplasty   More FDA Info for this Device
510(K) Number	K162864
Device Name	Methyl Methacrylate For Cranioplasty
Applicant	Skeletal Kinetics, LLC. 10201 Bubb Road Cupertino, CA 95014 US Other 510(k) Applications for this Company
Contact	Alicia Hemphill Other 510(k) Applications for this Contact
Regulation Number	882.5300   More FDA Info for this Regulation Number
Classification Product Code	GXP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/13/2016
Decision Date	01/13/2017
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