FDA 510(k) Application Details - K182154

Device Classification Name	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component   More FDA Info for this Device
510(K) Number	K182154
Device Name	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant	Synthes (USA) Products, LLC 1301 Goshen Parkway West Chester, PA 19380 US Other 510(k) Applications for this Company
Contact	Stephan Jepards Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	KTT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/09/2018
Decision Date	10/16/2018
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