FDA 510(k) Application Details - K160791

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K160791
Device Name	Screw, Fixation, Bone
Applicant	AmorChem Holdings, Inc. 1, Westmount Square Montreal H3Z 2P9 CA Other 510(k) Applications for this Company
Contact	KEVIN MCBRIDE 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	03/23/2016
Decision Date	11/15/2016
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