FDA product code NDI: Staple, Fixation, Bone, Metallic
NDI is the FDA product code for staple, fixation, bone, metallic. It is a Class II device, regulated under 21 CFR 888.3030 and reviewed by the Orthopedic panel. Devices under NDI reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Staple, Fixation, Bone, Metallic |
| Device class | Class II |
| Regulation | 21 CFR 888.3030 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
Recalls for NDI devices
openFDA lists no recalls for product code NDI.
Frequently asked questions
What is FDA product code NDI?
NDI is the FDA product code for staple, fixation, bone, metallic. It is a Class II device, regulated under 21 CFR 888.3030 and reviewed by the Orthopedic panel.
What device class is NDI?
Class II, regulation 21 CFR 888.3030. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NDI
- Run a recall and safety report across every NDI manufacturer
- Watch product code NDI 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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