FDA 510(k) Application Details - K151387

Device Classification Name	Fastener, Plate, Cranioplasty   More FDA Info for this Device
510(K) Number	K151387
Device Name	Fastener, Plate, Cranioplasty
Applicant	STRYKER 750 TRADE CENTRE WAY, SUITE 200 PORTAGE, MI 49002 US Other 510(k) Applications for this Company
Contact	JONATHAN SCHELL Other 510(k) Applications for this Contact
Regulation Number	882.5360   More FDA Info for this Regulation Number
Classification Product Code	HBW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/26/2015
Decision Date	06/24/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review