FDA product code HXT: Tape, Orthopedic
HXT is the FDA product code for tape, orthopedic. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. Devices under HXT reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Tape, Orthopedic |
| Device class | Class I |
| Regulation | 21 CFR 878.4800 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Recalls for HXT devices
openFDA lists no recalls for product code HXT.
Frequently asked questions
What is FDA product code HXT?
HXT is the FDA product code for tape, orthopedic. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel.
What device class is HXT?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code HXT
- Run a recall and safety report across every HXT manufacturer
- Watch product code HXT 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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