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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 K152259
Device Name InFill Interbody Fusion Device
Applicant
Pinnacle Spine Group, LLC
1601 Elm Street
Suite 1930
Dallas,  TX  75201
Applicant Contact Rebecca K Pine
Correspondent
Pinnacle Spine Group, LLC
1601 Elm Street
Suite 1930
Dallas,  TX  75201
Correspondent Contact Rebecca K Pine
Regulation Number888.3080
Classification Product Code
MAX  
Date Received08/11/2015
Decision Date 11/19/2015
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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