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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Integrated Fixation, Lumbar
510(k) Number K171567
Device Name IRIX-A Lumbar Integrated Fusion System
Applicant
X-Spine Systems, Inc.
452 Alexanderville Rd.
Miamisburg,  OH  45342
Applicant Contact Kriss Andersson
Correspondent
X-Spine Systems, Inc.
452 Alexanderville Rd.
Miamisburg,  OH  45342
Correspondent Contact Charlene Brumbaugh
Regulation Number888.3080
Classification Product Code
OVD  
Date Received05/30/2017
Decision Date 08/28/2017
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
Recalls CDRH Recalls
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