FDA 510(k) Application Details - K111065

Device Classification Name	Plate, Cranioplasty, Preformed, Alterable   More FDA Info for this Device
510(K) Number	K111065
Device Name	Plate, Cranioplasty, Preformed, Alterable
Applicant	HOWMEDICA OSTEONICS CORP. DBA STRYKER ORTHOPEADICS 325 Corporate Drive Mahwah, NJ 07430 US Other 510(k) Applications for this Company
Contact	CALUDIA WIESEMANN 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	04/18/2011
Decision Date	07/14/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review