FDA product code NDH: Nail, Fixation, Bone, Metallic
NDH is the FDA product code for nail, fixation, bone, metallic. It is a Class II device, regulated under 21 CFR 888.3030 and reviewed by the Orthopedic panel. Devices under NDH reach the market by 510(k); FDA lists no cleared 510(k)s for it. FDA has posted 3 recalls for NDH devices.
Classification
| Field | Value |
|---|---|
| Device name | Nail, 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 NDH devices
3 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2004-11-22.
Frequently asked questions
What is FDA product code NDH?
NDH is the FDA product code for nail, 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 NDH?
Class II, regulation 21 CFR 888.3030. Typical premarket route: 510(k).
Have NDH devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2004-11-22.
Next steps
- Run an FDA pathway report with predicate devices for product code NDH
- Run a recall and safety report across every NDH manufacturer
- Watch product code NDH 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.
All Orthopedic product codes · FDA product code lookup · 510(k) database search · 510(k) review times