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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 K121476
Device Name INFILL GRAFT DELIVERY SYSTEM
Applicant
PINNACLE SPINE GROUP, LLC
1601 elm st ste 300
dallas,  TX  75201
Contact rebecca k pine
Regulation Number880.5860
Classification Product Code
FMF  
Date Received05/18/2012
Decision Date 08/29/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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