FDA product code GXM: Anvil, Skull Plate
GXM is the FDA product code for anvil, skull plate. It is a Class I device, regulated under 21 CFR 882.4030 and reviewed by the Neurology panel. Devices under GXM reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Anvil, Skull Plate |
| Device class | Class I |
| Regulation | 21 CFR 882.4030 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) exempt |
Recalls for GXM devices
openFDA lists no recalls for product code GXM.
Frequently asked questions
What is FDA product code GXM?
GXM is the FDA product code for anvil, skull plate. It is a Class I device, regulated under 21 CFR 882.4030 and reviewed by the Neurology panel.
What device class is GXM?
Class I, regulation 21 CFR 882.4030. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code GXM
- Run a recall and safety report across every GXM manufacturer
- Watch product code GXM 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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