FDA product code NUD: Vertebroplasty Compound, Calcium Based
NUD is the FDA product code for vertebroplasty compound, calcium based. It is a Class II device, regulated under 21 CFR 888.3027 and reviewed by the Orthopedic panel. Devices under NUD reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
THIS DEVICE IS INDICATED FOR THE FIXATION OF PATHOLOGICAL FRACTURES OF THE VERTEBRAL BODY USING VERTEBROPLASTY OR KYPHOPLASTY PROCEDURES. THE DEVICE RESORBS (TIME FRAME MAY BE INDICATED) AND IS REPLACED WITH BONE DURING THE HEALING PROCESS.
Classification
| Field | Value |
|---|---|
| Device name | Vertebroplasty Compound, Calcium Based |
| Device class | Class II |
| Regulation | 21 CFR 888.3027 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
Recalls for NUD devices
openFDA lists no recalls for product code NUD.
Frequently asked questions
What is FDA product code NUD?
NUD is the FDA product code for vertebroplasty compound, calcium based. It is a Class II device, regulated under 21 CFR 888.3027 and reviewed by the Orthopedic panel.
What device class is NUD?
Class II, regulation 21 CFR 888.3027. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NUD
- Run a recall and safety report across every NUD manufacturer
- Watch product code NUD 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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