FDA product code NDE: Rod, Fixation, Intramedullary And Accessories, Metallic And Non-Collapsible
NDE is the FDA product code for rod, fixation, intramedullary and accessories, metallic and non-collapsible. It is a Class II device, regulated under 21 CFR 888.3020 and reviewed by the Orthopedic panel. Devices under NDE reach the market by 510(k); FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for NDE devices.
Classification
| Field | Value |
|---|---|
| Device name | Rod, Fixation, Intramedullary And Accessories, Metallic And Non-Collapsible |
| Device class | Class II |
| Regulation | 21 CFR 888.3020 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
Recalls for NDE devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-11-09.
Frequently asked questions
What is FDA product code NDE?
NDE is the FDA product code for rod, fixation, intramedullary and accessories, metallic and non-collapsible. It is a Class II device, regulated under 21 CFR 888.3020 and reviewed by the Orthopedic panel.
What device class is NDE?
Class II, regulation 21 CFR 888.3020. Typical premarket route: 510(k).
Have NDE devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2016-11-09.
Next steps
- Run an FDA pathway report with predicate devices for product code NDE
- Run a recall and safety report across every NDE manufacturer
- Watch product code NDE 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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