FDA product code LWA: Prosthesis, Ligament, Ptfe
LWA is the FDA product code for prosthesis, ligament, ptfe. It is a Class III device, reviewed by the Orthopedic panel. Devices under LWA reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Ligament, Ptfe |
| Device class | Class III |
| Review panel | OR — Orthopedic |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for LWA devices
openFDA lists no recalls for product code LWA.
Frequently asked questions
What is FDA product code LWA?
LWA is the FDA product code for prosthesis, ligament, ptfe. It is a Class III device, reviewed by the Orthopedic panel.
What device class is LWA?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code LWA
- Run a recall and safety report across every LWA manufacturer
- Watch product code LWA 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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