Device |
platelet and plasma separator for bone graft handling |
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and/or filtration methods to separate the whole blood into components, after which the platelet rich plasma is withdrawn.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 Code | ORG |
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 Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Recognized Consensus Standard
|
Third Party Review |
Not Third Party Eligible |