FDA product code NDD: Cerclage, Fixation, Metallic
NDD is the FDA product code for cerclage, fixation, metallic. It is a Class II device, regulated under 21 CFR 888.3010 and reviewed by the Orthopedic panel. FDA has cleared 1 510(k) submission under NDD. The average 510(k) review took 182 days (median 182).
Classification
| Field | Value |
|---|---|
| Device name | Cerclage, Fixation, Metallic |
| Device class | Class II |
| Regulation | 21 CFR 888.3010 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every NDD clearance
Top NDD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Whiteside Biomechanics, Inc. | 1 | 2001-05-23 |
Most recent NDD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K003618 | Whiteside Biomechanics, Inc. | WHITESIDE BIOMECHANICS LOW PROFILE STAINLESS STEEL CABLE SYSTEM, MODEL BIO-1-1014 | 2001-05-23 | 182 |
Recalls for NDD devices
openFDA lists no recalls for product code NDD.
Frequently asked questions
What is FDA product code NDD?
NDD is the FDA product code for cerclage, fixation, metallic. It is a Class II device, regulated under 21 CFR 888.3010 and reviewed by the Orthopedic panel.
What device class is NDD?
Class II, regulation 21 CFR 888.3010. Typical premarket route: 510(k).
How long does a 510(k) take for product code NDD?
Across 1 cleared submissions the average was 182 days from receipt to decision (median 182).
Which companies have the most NDD clearances?
Whiteside Biomechanics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NDD
- Run a recall and safety report across every NDD manufacturer
- Watch product code NDD 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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