FDA 510(k) Application Details - K131591

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K131591
Device Name	Screw, 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	888.3040   More FDA Info for this Regulation Number
Classification Product Code	HWC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/31/2013
Decision Date	11/27/2013
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