FDA product code ORG: Platelet And Plasma Separator For Bone Graft Handling
ORG is the FDA product code for platelet and plasma separator for bone graft handling. It is a Class II device, regulated under 21 CFR 864.9245 and reviewed by the Hematology panel. Devices under ORG reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Preparation of autologous platelet rich plasma from a small sample of peripheral blood for mixing with bone graft to improve handling characteristics.
Classification
| Field | Value |
|---|---|
| Device name | Platelet And Plasma Separator For Bone Graft Handling |
| Device class | Class II |
| Regulation | 21 CFR 864.9245 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
Recalls for ORG devices
openFDA lists no recalls for product code ORG.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- P9020 — Platelet rich plasma, each unit
Frequently asked questions
What is FDA product code ORG?
ORG is the FDA product code for platelet and plasma separator for bone graft handling. It is a Class II device, regulated under 21 CFR 864.9245 and reviewed by the Hematology panel.
What device class is ORG?
Class II, regulation 21 CFR 864.9245. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code ORG
- Run a recall and safety report across every ORG manufacturer
- Watch product code ORG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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