FDA 510(k) Application Details - K112557

Device Classification Name	Plate, Cranioplasty, Preformed, Alterable   More FDA Info for this Device
510(K) Number	K112557
Device Name	Plate, Cranioplasty, Preformed, Alterable
Applicant	Stryker 750 TRADE CENTRE WAY STE 200 PORTAGE, MI 49002 US Other 510(k) Applications for this Company
Contact	ROB YAMASHITA 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	09/02/2011
Decision Date	01/05/2012
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