FDA product code PBU: Bone Void Filler, Syringe
PBU is the FDA product code for bone void filler, syringe. It is a Not classified device, reviewed by the Orthopedic panel. Devices under PBU reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Definition
To fill bony voids or gaps of the skeletal system (i.e. the extremities, posterolateral spine and pelvis).
Classification
| Field | Value |
|---|---|
| Device name | Bone Void Filler, Syringe |
| Device class | Not classified |
| Review panel | OR — Orthopedic |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
| Implant | Yes |
Recalls for PBU devices
openFDA lists no recalls for product code PBU.
Frequently asked questions
What is FDA product code PBU?
PBU is the FDA product code for bone void filler, syringe. It is a Not classified device, reviewed by the Orthopedic panel.
What device class is PBU?
Not classified. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code PBU
- Run a recall and safety report across every PBU manufacturer
- Watch product code PBU 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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