FDA product code HSA: Prosthesis, Knee, Hemi-, Femoral
HSA is the FDA product code for prosthesis, knee, hemi-, femoral. It is a Class III device, regulated under 21 CFR 888.3570 and reviewed by the Orthopedic panel. Devices under HSA reach the market by PMA; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Knee, Hemi-, Femoral |
| Device class | Class III |
| Regulation | 21 CFR 888.3570 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | PMA |
| Implant | Yes |
Recalls for HSA devices
openFDA lists no recalls for product code HSA.
Frequently asked questions
What is FDA product code HSA?
HSA is the FDA product code for prosthesis, knee, hemi-, femoral. It is a Class III device, regulated under 21 CFR 888.3570 and reviewed by the Orthopedic panel.
What device class is HSA?
Class III, regulation 21 CFR 888.3570. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code HSA
- Run a recall and safety report across every HSA manufacturer
- Watch product code HSA 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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