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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name platelet and plasma separator for bone graft handling
510(k) Number BK120008
Tradename FIBRINET (R) Autologous PRP System
Device Name Platelet And Plasma Separator For Bone Graft Handling
Original Applicant
Vertical Spine, LLC
2201 marconi road
wall,  NJ  07719
Regulation Number864.9245
Classification Product Code
ORG  
Date Received02/24/2012
Decision Date 08/01/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No
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