FDA product code HBX: Instrument, Cranioplasty Material Forming
HBX is the FDA product code for instrument, cranioplasty material forming. It is a Class I device, regulated under 21 CFR 882.4500 and reviewed by the Neurology panel. Devices under HBX reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 3 recalls for HBX devices.
Classification
| Field | Value |
|---|---|
| Device name | Instrument, Cranioplasty Material Forming |
| Device class | Class I |
| Regulation | 21 CFR 882.4500 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) exempt |
Recalls for HBX devices
3 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-12-03.
Frequently asked questions
What is FDA product code HBX?
HBX is the FDA product code for instrument, cranioplasty material forming. It is a Class I device, regulated under 21 CFR 882.4500 and reviewed by the Neurology panel.
What device class is HBX?
Class I, regulation 21 CFR 882.4500. Typical premarket route: 510(k) exempt.
Have HBX devices been recalled?
Yes: 3 product recalls across 1 recall events; the most recent began 2010-12-03.
Next steps
- Run an FDA pathway report with predicate devices for product code HBX
- Run a recall and safety report across every HBX manufacturer
- Watch product code HBX 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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