FDA product code HWF: Prosthesis, Ligament
HWF is the FDA product code for prosthesis, ligament. It is a Class III device, reviewed by the Orthopedic panel. Devices under HWF reach the market by PMA; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Ligament |
| Device class | Class III |
| Review panel | OR — Orthopedic |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for HWF devices
openFDA lists no recalls for product code HWF.
Frequently asked questions
What is FDA product code HWF?
HWF is the FDA product code for prosthesis, ligament. It is a Class III device, reviewed by the Orthopedic panel.
What device class is HWF?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code HWF
- Run a recall and safety report across every HWF manufacturer
- Watch product code HWF 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.