FDA product code LTO: Spacer, Cement
LTO is the FDA product code for spacer, cement. It is a Class III device, regulated under 21 CFR 888.3320 and reviewed by the Orthopedic panel. Devices under LTO reach the market by PMA; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Spacer, Cement |
| Device class | Class III |
| Regulation | 21 CFR 888.3320 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | PMA |
| Implant | Yes |
Recalls for LTO devices
openFDA lists no recalls for product code LTO.
Frequently asked questions
What is FDA product code LTO?
LTO is the FDA product code for spacer, cement. It is a Class III device, regulated under 21 CFR 888.3320 and reviewed by the Orthopedic panel.
What device class is LTO?
Class III, regulation 21 CFR 888.3320. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code LTO
- Run a recall and safety report across every LTO manufacturer
- Watch product code LTO 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.