FDA product code PFM: Hemibridge System
PFM is the FDA product code for hemibridge system. It is a Not classified device, reviewed by the Orthopedic panel. Devices under PFM reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Definition
Non-fusion growth modulation of spinal column.
Classification
| Field | Value |
|---|---|
| Device name | Hemibridge System |
| Device class | Not classified |
| Review panel | OR — Orthopedic |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
| Implant | Yes |
Recalls for PFM devices
openFDA lists no recalls for product code PFM.
Frequently asked questions
What is FDA product code PFM?
PFM is the FDA product code for hemibridge system. It is a Not classified device, reviewed by the Orthopedic panel.
What device class is PFM?
Not classified. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code PFM
- Run a recall and safety report across every PFM manufacturer
- Watch product code PFM 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.