FDA product code OSE: Patient Specific Manual Navigation System
OSE is the FDA product code for patient specific manual navigation system. It is a Class II device, regulated under 21 CFR 882.4560 and reviewed by the Orthopedic panel. Devices under OSE reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Intended for defining implant alignment relative to a patient's anatomy.
Classification
| Field | Value |
|---|---|
| Device name | Patient Specific Manual Navigation System |
| Device class | Class II |
| Regulation | 21 CFR 882.4560 |
| Review panel | OR — Orthopedic |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
Recalls for OSE devices
openFDA lists no recalls for product code OSE.
Frequently asked questions
What is FDA product code OSE?
OSE is the FDA product code for patient specific manual navigation system. It is a Class II device, regulated under 21 CFR 882.4560 and reviewed by the Orthopedic panel.
What device class is OSE?
Class II, regulation 21 CFR 882.4560. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code OSE
- Run a recall and safety report across every OSE manufacturer
- Watch product code OSE 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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