FDA 510(k) Application Details - K143661

Device Classification Name	Methyl Methacrylate For Cranioplasty   More FDA Info for this Device
510(K) Number	K143661
Device Name	Methyl Methacrylate For Cranioplasty
Applicant	STRYKER 750 TRADE CENTRE WAY - SUITE 200 PORTAGE, MI 49002 US Other 510(k) Applications for this Company
Contact	Nathan VanSweden 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	12/23/2014
Decision Date	09/02/2015
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