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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spine, Plate, Laminoplasty, Metal
510(k) Number K160114
Device Name Xspan Laminoplasty Fixation System
Applicant
X-Spine Systems, Inc.
452 Alexandersville Rd.
Miamisburg,  OH  45342
Applicant Contact Kriss Anderson
Correspondent
X-Spine Systems, Inc.
452 Alexandersville Rd.
Miamisburg,  OH  45342
Correspondent Contact Kriss Anderson
Regulation Number888.3050
Classification Product Code
NQW  
Date Received01/19/2016
Decision Date 03/15/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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