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U.S. Department of Health and Human Services

Product Classification

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Device platelet and plasma separator for bone graft handling
Regulation Description Automated blood cell separator.
Definition Preparation of autologous platelet rich plasma from a small sample of peripheral blood for mixing with bone graft to improve handling characteristics.
Physical State May include centrifuge, filters, tubes, syringes and needles
Technical Method Uses centrifugal and/or filtration methods to separate the whole blood into components, after which the platelet rich plasma is withdrawn.
Target Area Blood drawn from peripheral veins, PRP applied to bony defects
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeORG
Premarket Review Center for Biologics Evaluation & Research (CBER)
Submission Type 510(k)
Regulation Number 864.9245
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible