FDA product code HTM: Stimulator, Osteogenesis, Electric, Battery-Operated, Invasive
HTM is the FDA product code for stimulator, osteogenesis, electric, battery-operated, invasive. It is a Class III device, reviewed by the Orthopedic panel. Devices under HTM reach the market by PMA; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Osteogenesis, Electric, Battery-Operated, Invasive |
| Device class | Class III |
| Review panel | OR — Orthopedic |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for HTM devices
openFDA lists no recalls for product code HTM.
Frequently asked questions
What is FDA product code HTM?
HTM is the FDA product code for stimulator, osteogenesis, electric, battery-operated, invasive. It is a Class III device, reviewed by the Orthopedic panel.
What device class is HTM?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code HTM
- Run a recall and safety report across every HTM manufacturer
- Watch product code HTM 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.
All Orthopedic product codes · FDA product code lookup · 510(k) database search · 510(k) review times