FDA product code HWO: Skid, Bone
HWO is the FDA product code for skid, bone. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel. Devices under HWO reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Skid, Bone |
| Device class | Class I |
| Regulation | 21 CFR 888.4540 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
Recalls for HWO devices
openFDA lists no recalls for product code HWO.
Frequently asked questions
What is FDA product code HWO?
HWO is the FDA product code for skid, bone. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel.
What device class is HWO?
Class I, regulation 21 CFR 888.4540. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code HWO
- Run a recall and safety report across every HWO manufacturer
- Watch product code HWO 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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