FDA 510(k) Application Details - K162507

Device Classification Name	Plate, Fixation, Bone   More FDA Info for this Device
510(K) Number	K162507
Device Name	Plate, Fixation, Bone
Applicant	TRUEMED GROUP, LLC 20507 NANNETTE LN SPRINT, TX 77388 US Other 510(k) Applications for this Company
Contact	Jorge Castillo 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	09/08/2016
Decision Date	08/03/2017
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