FDA 510(k) Application Details - K141385

Device Classification Name	Fastener, Plate, Cranioplasty   More FDA Info for this Device
510(K) Number	K141385
Device Name	Fastener, Plate, Cranioplasty
Applicant	DEPUY SYNTHES COMPANIES OF JOHNSON & JOHNSON 1230 WILSON DRIVE WEST CHESTER, PA 19380 US Other 510(k) Applications for this Company
Contact	JEFFREY DOW 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	05/27/2014
Decision Date	03/27/2015
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