HBW
- Product code
- HBW
- Device name
- Fastener, Plate, Cranioplasty
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.5360
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 7
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251472 | 2025-07-11 | Inion OY | Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; |
Official FDA classification page: HBW
Classification and pathway per current FDA publications. Data from openFDA (CC0).