GWO
- Product code
- GWO
- Device name
- Plate, Cranioplasty, Preformed, Alterable
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.5320
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 4
- Summaries archived here
- 3 (direct download)
- 510(k) clearances (all years, FDA)
- 43 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261058 | 2026-07-29 | CraniUS, LLC | CraniUS Plate | |
| K250297 | 2025-10-27 | Techfit Digital Surgery, Inc. | TECHFIT Patient-Specific Cranial System | |
| K250334 | 2025-07-25 | Kelyniam Global, Inc. | Fusion Craniofacial Implant; Fusion Skull Implant | |
| K231834 | 2024-04-04 | 3D Systems, Inc. | VSP PEEK Cranial Implant | FDA |
Official FDA classification page: GWO
Classification and pathway per current FDA publications. Data from openFDA (CC0).