FDA 510(k) Application Details - K160114

Device Classification Name	Orthosis, Spine, Plate, Laminoplasty, Metal   More FDA Info for this Device
510(K) Number	K160114
Device Name	Orthosis, Spine, Plate, Laminoplasty, Metal
Applicant	X-SPINE SYSTEMS, INC. 452 ALEXANDERSVILLE RD. MIAMISBURG, OH 45342 US Other 510(k) Applications for this Company
Contact	Kriss Anderson Other 510(k) Applications for this Contact
Regulation Number	888.3050   More FDA Info for this Regulation Number
Classification Product Code	NQW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/19/2016
Decision Date	03/15/2016
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