FDA 510(k) Application Details - K133082

Device Classification Name	Plate, Cranioplasty, Preformed, Non-Alterable   More FDA Info for this Device
510(K) Number	K133082
Device Name	Plate, Cranioplasty, Preformed, Non-Alterable
Applicant	OSTEOSYMBIONICS, LLC 1768 EAST 25TH STREET SUITE 316 CLEVELAND, OH 44114 US Other 510(k) Applications for this Company
Contact	NICHOLAS WLKINS Other 510(k) Applications for this Contact
Regulation Number	882.5330   More FDA Info for this Regulation Number
Classification Product Code	GXN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2013
Decision Date	05/20/2014
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