FDA product code OJM: Resorbable Spinal Intervertebral Body Fixation Orthosis - Mesh
OJM is the FDA product code for resorbable spinal intervertebral body fixation orthosis - mesh. It is a Class II device, regulated under 21 CFR 888.3060 and reviewed by the Orthopedic panel. Devices under OJM reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Maintain position of bone graft in spinal fusion procedures. Intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts, in conjunction with traditional rigid fixation.
Classification
| Field | Value |
|---|---|
| Device name | Resorbable Spinal Intervertebral Body Fixation Orthosis - Mesh |
| Device class | Class II |
| Regulation | 21 CFR 888.3060 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
Recalls for OJM devices
openFDA lists no recalls for product code OJM.
Frequently asked questions
What is FDA product code OJM?
OJM is the FDA product code for resorbable spinal intervertebral body fixation orthosis - mesh. It is a Class II device, regulated under 21 CFR 888.3060 and reviewed by the Orthopedic panel.
What device class is OJM?
Class II, regulation 21 CFR 888.3060. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code OJM
- Run a recall and safety report across every OJM manufacturer
- Watch product code OJM 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.