FDA 510(k) Application Details - K163489

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K163489
Device Name	Screw, Fixation, Bone
Applicant	Ortho SOlutions UK Limited West Station Business Park, Spital Road Maldon CM9 6FF GB Other 510(k) Applications for this Company
Contact	Craig Bluett 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	12/12/2016
Decision Date	03/08/2017
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