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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K143488
Device Name InFill Graft Delivery System
Applicant
Pinnacle Spine Group, LLC
1601 Elm St.
Suite 300
Dallas,  TX  75201
Applicant Contact Rebecca K Pine
Correspondent
Pinnacle Spine Group, LLC
1601 Elm St.
Suite 300
Dallas,  TX  75201
Correspondent Contact Rebecca K Pine
Regulation Number880.5860
Classification Product Code
FMF  
Date Received12/08/2014
Decision Date 12/17/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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