FDA 510(k) Application Details - K143245

Device Classification Name	Rod, Fixation, Intramedullary And Accessories   More FDA Info for this Device
510(K) Number	K143245
Device Name	Rod, Fixation, Intramedullary And Accessories
Applicant	GPC MEDICAL LIMITED PLOT NUMBER 8, SHUBH PLAZA M-BLOCK DDA LSC, VIKAS PURI NEW DELHI 110018 IN Other 510(k) Applications for this Company
Contact	Vikas Narang Other 510(k) Applications for this Contact
Regulation Number	888.3020   More FDA Info for this Regulation Number
Classification Product Code	HSB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/12/2014
Decision Date	09/30/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review