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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 Bone Graft, Lumbar
510(k) Number K151819
Device Name Integrity Spine Lumbar Interbody Fusion System
Applicant
Integrity Spine Lumbar Interbody Fusion System
2800 NE Loop 410 Suite 203
San Antonio,  TX  78218
Applicant Contact LISA PETERSON
Correspondent
Kaedon Consulting, LLC
14001 Hunters Pass
Austin,  TX  78734
Correspondent Contact LISA PETERSON
Regulation Number888.3080
Classification Product Code
MAX  
Date Received07/06/2015
Decision Date 11/10/2015
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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