FDA 510(k) Application Details - K161048

Device Classification Name	Plate, Fixation, Bone   More FDA Info for this Device
510(K) Number	K161048
Device Name	Plate, Fixation, Bone
Applicant	CONVENTUS ORTHOPAEDICS, INC. 10200 73RD AVENUE NORTH, SUITE 122 MAPLE GROVE, MN 55369 US Other 510(k) Applications for this Company
Contact	KENT LIND 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	04/14/2016
Decision Date	07/26/2016
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