FDA 510(k) Application Details - K122541

Device Classification Name	Appliance, Fixation, Nail/Blade/Plate Combination, Single Component   More FDA Info for this Device
510(K) Number	K122541
Device Name	Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
Applicant	ORTHOFIX SRL 22423 SKYVIEW DRIVE WEST LINN, OR 97068 US Other 510(k) Applications for this Company
Contact	CANDACE F CEDERMAN Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	KTW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/21/2012
Decision Date	09/20/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review