FDA 510(k) Application Details - K160428

Device Classification Name	Orthosis, Cervical Pedicle Screw Spinal Fixation   More FDA Info for this Device
510(K) Number	K160428
Device Name	Orthosis, Cervical Pedicle Screw Spinal Fixation
Applicant	X-spine Systems, Inc. 452 Alexandersville Rd. Miamisburg, OH 45342 US Other 510(k) Applications for this Company
Contact	David Kirschman Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	NKG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/16/2016
Decision Date	05/05/2016
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