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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K170530
Device Name Butrex Lumbar Buttress Plating 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 Number888.3060
Classification Product Code
KWQ  
Date Received02/22/2017
Decision Date 03/22/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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