FDA 510(k) Application Details - K163003

Device Classification Name	Plate, Fixation, Bone   More FDA Info for this Device
510(K) Number	K163003
Device Name	Plate, Fixation, Bone
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	888.3030   More FDA Info for this Regulation Number
Classification Product Code	HRS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/28/2016
Decision Date	03/16/2017
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