FDA product code NDM: Pin, Fixation, Threaded, Metallic
NDM is the FDA product code for pin, fixation, threaded, metallic. It is a Class II device, regulated under 21 CFR 888.3040 and reviewed by the Orthopedic panel. FDA has cleared 1 510(k) submission under NDM. The average 510(k) review took 105 days (median 105).
Classification
| Field | Value |
|---|---|
| Device name | Pin, Fixation, Threaded, Metallic |
| Device class | Class II |
| Regulation | 21 CFR 888.3040 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
Top NDM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sterilmed, Inc. | 1 | 2010-06-25 |
Most recent NDM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K100707 | Sterilmed, Inc. | REPROCESSED PINS | 2010-06-25 | 105 |
Recalls for NDM devices
openFDA lists no recalls for product code NDM.
Frequently asked questions
What is FDA product code NDM?
NDM is the FDA product code for pin, fixation, threaded, metallic. It is a Class II device, regulated under 21 CFR 888.3040 and reviewed by the Orthopedic panel.
What device class is NDM?
Class II, regulation 21 CFR 888.3040. Typical premarket route: 510(k).
How long does a 510(k) take for product code NDM?
Across 1 cleared submissions the average was 105 days from receipt to decision (median 105).
Which companies have the most NDM clearances?
Sterilmed, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NDM
- Run a recall and safety report across every NDM manufacturer
- Watch product code NDM 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.