ORG

Platelet And Plasma Separator For Bone Graft Handling

Product code: ORG
Device name: Platelet And Plasma Separator For Bone Graft Handling
Device class: Class 2
21 CFR: 21 CFR 864.9245
Medical specialty: Hematology
Marketing pathway: 510(K)

FDA classification definition

Preparation of autologous platelet rich plasma from a small sample of peripheral blood for mixing with bone graft to improve handling characteristics.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: ORG

Classification and pathway per current FDA publications. Data from openFDA (CC0).