FDA 510(k) Application Details - K160545

Device Classification Name	Rod, Fixation, Intramedullary And Accessories   More FDA Info for this Device
510(K) Number	K160545
Device Name	Rod, Fixation, Intramedullary And Accessories
Applicant	PEGA MEDICAL INC. 1111 AUTOROUTE CHOMEDEY LAVAL H7W 5J8 CA Other 510(k) Applications for this Company
Contact	Ariel R. Dujovne 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	02/26/2016
Decision Date	11/23/2016
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