Platelet And Plasma Separator For Bone Graft Handling
The Platelet and Plasma Separator for Bone Graft Handling (product code ORG) is a hematology device used to prepare autologous platelet-rich plasma from a small peripheral blood sample. The resulting platelet-rich plasma is mixed with bone graft material to improve its handling characteristics during surgical procedures. As an FDA Class 2 device under regulation 864.9245, it requires 510(k) premarket clearance and falls within the Hematology specialty. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- ORG
- Device Class
- FDA class 2
- Regulation Number
- 864.9245
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 1
Device Characteristics
Definition
Preparation of autologous platelet rich plasma from a small sample of peripheral blood for mixing with bone graft to improve handling characteristics.
FEI Numbers
This FDA classification entry is associated with 105 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 105 registration numbers. Click on an entry to view related FDA registrations.