FDA product code NDK: System, External Fixator (With Metallic Invasive Components)
NDK is the FDA product code for system, external fixator (with metallic invasive components). It is a Class II device, regulated under 21 CFR 888.3040 and reviewed by the Orthopedic panel. FDA has cleared 3 510(k) submissions under NDK, from 3 different applicants. The average 510(k) review took 187 days (median 148).
Classification
| Field | Value |
|---|---|
| Device name | System, External Fixator (With Metallic Invasive Components) |
| Device class | Class II |
| Regulation | 21 CFR 888.3040 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every NDK clearance
Top NDK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| 3D Medical Concepts, LLC | 1 | 2014-12-29 |
| Christopher D. Endara | 1 | 2012-12-20 |
| TriMed, Inc. | 1 | 2010-09-15 |
Most recent NDK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K140649 | 3D Medical Concepts, LLC | VECTRIX EXTERNAL FIXATOR | 2014-12-29 | 291 |
| K122208 | Christopher D. Endara | EXTERNAL FIXATOR SYSTEM | 2012-12-20 | 148 |
| K101375 | TriMed, Inc. | TRIMED X-FIX | 2010-09-15 | 121 |
Recalls for NDK devices
openFDA lists no recalls for product code NDK.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- L8614 — Cochlear device, includes all internal and external components
Frequently asked questions
What is FDA product code NDK?
NDK is the FDA product code for system, external fixator (with metallic invasive components). It is a Class II device, regulated under 21 CFR 888.3040 and reviewed by the Orthopedic panel.
What device class is NDK?
Class II, regulation 21 CFR 888.3040. Typical premarket route: 510(k).
How long does a 510(k) take for product code NDK?
Across 3 cleared submissions the average was 187 days from receipt to decision (median 148).
Which companies have the most NDK clearances?
3D Medical Concepts, LLC (1); Christopher D. Endara (1); TriMed, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NDK
- Run a recall and safety report across every NDK manufacturer
- Watch product code NDK 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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