FDA product code NNS: Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Non-Sterile
NNS is the FDA product code for instrument, prosthesis modification for ossicular replacement surgery, non-sterile. It is a Class I device, regulated under 21 CFR 874.3540 and reviewed by the Ear, Nose and Throat panel. Devices under NNS reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
Prosthesis modification instrument for ossicular replacement surgery; see product code LRE.
Classification
| Field | Value |
|---|---|
| Device name | Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Non-Sterile |
| Device class | Class I |
| Regulation | 21 CFR 874.3540 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for NNS devices
openFDA lists no recalls for product code NNS.
Frequently asked questions
What is FDA product code NNS?
NNS is the FDA product code for instrument, prosthesis modification for ossicular replacement surgery, non-sterile. It is a Class I device, regulated under 21 CFR 874.3540 and reviewed by the Ear, Nose and Throat panel.
What device class is NNS?
Class I, regulation 21 CFR 874.3540. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code NNS
- Run a recall and safety report across every NNS manufacturer
- Watch product code NNS 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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