FDA product code NDF: Plate, Fixation, Bone, Non-Spinal, Metallic
NDF is the FDA product code for plate, fixation, bone, non-spinal, metallic. It is a Class II device, regulated under 21 CFR 888.3030 and reviewed by the Orthopedic panel. FDA has cleared 3 510(k) submissions under NDF, from 2 different applicants. The average 510(k) review took 73 days (median 76). FDA has posted 1 recall for NDF devices.
Classification
| Field | Value |
|---|---|
| Device name | Plate, Fixation, Bone, Non-Spinal, Metallic |
| Device class | Class II |
| Regulation | 21 CFR 888.3030 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every NDF clearance
Top NDF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ebi, L.P. | 2 | 2002-08-12 |
| I.T.S. Implantat-Technologie-Systeme GmbH | 1 | 2005-08-22 |
Most recent NDF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K051642 | I.T.S. Implantat-Technologie-Systeme GmbH | FR.O.H. CALCANEUS REPAIR SYSTEM | 2005-08-22 | 63 |
| K021749 | Ebi, L.P. | EBI DYNAFIX VS OSTEOTOMY SYSTEM | 2002-08-12 | 76 |
| K010551 | Ebi, L.P. | EBI DYNAFIX VS OSTEOTOMY SYSTEM | 2001-05-17 | 80 |
Recalls for NDF devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-10-11.
Frequently asked questions
What is FDA product code NDF?
NDF is the FDA product code for plate, fixation, bone, non-spinal, metallic. It is a Class II device, regulated under 21 CFR 888.3030 and reviewed by the Orthopedic panel.
What device class is NDF?
Class II, regulation 21 CFR 888.3030. Typical premarket route: 510(k).
How long does a 510(k) take for product code NDF?
Across 3 cleared submissions the average was 73 days from receipt to decision (median 76).
Which companies have the most NDF clearances?
Ebi, L.P. (2); I.T.S. Implantat-Technologie-Systeme GmbH (1).
Have NDF devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2013-10-11.
Next steps
- Run an FDA pathway report with predicate devices for product code NDF
- Run a recall and safety report across every NDF manufacturer
- Watch product code NDF 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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