FDA 510(k) Application Details - K161894

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K161894
Device Name	Screw, Fixation, Bone
Applicant	SURGTECH INC 24600 CENTER RIDGE ROAD, SUITE 195, WESTLAKE, OH 44145 US Other 510(k) Applications for this Company
Contact	XUEGONG YU 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	07/11/2016
Decision Date	02/21/2017
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