FDA product code LML: Ligaments And Tendons, Synthetic
LML is the FDA product code for ligaments and tendons, synthetic. It is a Class III device, reviewed by the Orthopedic panel. Devices under LML reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code.
Classification
| Field | Value |
|---|---|
| Device name | Ligaments And Tendons, Synthetic |
| Device class | Class III |
| Review panel | OR — Orthopedic |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for LML devices
openFDA lists no recalls for product code LML.
Frequently asked questions
What is FDA product code LML?
LML is the FDA product code for ligaments and tendons, synthetic. It is a Class III device, reviewed by the Orthopedic panel.
What device class is LML?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code LML
- Run a recall and safety report across every LML manufacturer
- Watch product code LML 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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