FDA product code LOE: Stimulator, Invasive Bone Growth
LOE is the FDA product code for stimulator, invasive bone growth. It is a Class III device, reviewed by the Orthopedic panel. Devices under LOE reach the market by PMA; FDA lists no cleared 510(k)s for it. 3 PMA applications cite this product code. FDA has posted 4 recalls for LOE devices.
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Invasive Bone Growth |
| Device class | Class III |
| Review panel | OR — Orthopedic |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for LOE devices
4 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-02-19.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2018 | 2 |
Frequently asked questions
What is FDA product code LOE?
LOE is the FDA product code for stimulator, invasive bone growth. It is a Class III device, reviewed by the Orthopedic panel.
What device class is LOE?
Class III. Typical premarket route: PMA.
Have LOE devices been recalled?
Yes: 4 product recalls across 2 recall events; the most recent began 2018-02-19.
Next steps
- Run an FDA pathway report with predicate devices for product code LOE
- Run a recall and safety report across every LOE manufacturer
- Watch product code LOE 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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