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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 BK241083
Tradename Platelet Rich Plasma (PRP) Device
Device Name Platelet And Plasma Separator For Bone Graft Handling
Original Applicant
OrthoAscent
6151 thornton avenue
suite 400
des moines,  IA  50321
Regulation Number864.9245
Classification Product Code
ORG  
Date Received06/28/2024
Decision Date 09/26/2024
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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