FDA product code MCV: Spinal Pedicle Screw, Fixation, Appliance System
MCV is the FDA product code for spinal pedicle screw, fixation, appliance system. It is a Class III device, reviewed by the Orthopedic panel. Devices under MCV reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Classification
| Field | Value |
|---|---|
| Device name | Spinal Pedicle Screw, Fixation, Appliance System |
| Device class | Class III |
| Review panel | OR — Orthopedic |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for MCV devices
openFDA lists no recalls for product code MCV.
Frequently asked questions
What is FDA product code MCV?
MCV is the FDA product code for spinal pedicle screw, fixation, appliance system. It is a Class III device, reviewed by the Orthopedic panel.
What device class is MCV?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code MCV
- Run a recall and safety report across every MCV manufacturer
- Watch product code MCV 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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