FDA product code NDJ: Screw, Fixation, Bone, Non-Spinal, Metallic
NDJ is the FDA product code for screw, fixation, bone, non-spinal, metallic. It is a Class II device, regulated under 21 CFR 888.3040 and reviewed by the Orthopedic panel. Devices under NDJ reach the market by 510(k); FDA lists no cleared 510(k)s for it. FDA has posted 13 recalls for NDJ devices.
Classification
| Field | Value |
|---|---|
| Device name | Screw, Fixation, Bone, Non-Spinal, Metallic |
| Device class | Class II |
| Regulation | 21 CFR 888.3040 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
Recalls for NDJ devices
13 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-04-29.
Frequently asked questions
What is FDA product code NDJ?
NDJ is the FDA product code for screw, fixation, bone, non-spinal, metallic. It is a Class II device, regulated under 21 CFR 888.3040 and reviewed by the Orthopedic panel.
What device class is NDJ?
Class II, regulation 21 CFR 888.3040. Typical premarket route: 510(k).
Have NDJ devices been recalled?
Yes: 13 product recalls across 4 recall events; the most recent began 2015-04-29.
Next steps
- Run an FDA pathway report with predicate devices for product code NDJ
- Run a recall and safety report across every NDJ manufacturer
- Watch product code NDJ 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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