FDA product code OBM: Cement, Bone, Vertebroplasty, Pre-Formed, Modular
OBM is the FDA product code for cement, bone, vertebroplasty, pre-formed, modular. It is a Class II device, regulated under 21 CFR 888.3027 and reviewed by the Orthopedic panel. Devices under OBM reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Reduction of vertebral body fractures in conjunction with PMMA bone cement cleared for vertebroplasty and restoration of vertebral body height.
Classification
| Field | Value |
|---|---|
| Device name | Cement, Bone, Vertebroplasty, Pre-Formed, Modular |
| Device class | Class II |
| Regulation | 21 CFR 888.3027 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
Recalls for OBM devices
openFDA lists no recalls for product code OBM.
Frequently asked questions
What is FDA product code OBM?
OBM is the FDA product code for cement, bone, vertebroplasty, pre-formed, modular. It is a Class II device, regulated under 21 CFR 888.3027 and reviewed by the Orthopedic panel.
What device class is OBM?
Class II, regulation 21 CFR 888.3027. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code OBM
- Run a recall and safety report across every OBM manufacturer
- Watch product code OBM 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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