GXN
- Product code
- GXN
- Device name
- Plate, Cranioplasty, Preformed, Non-Alterable
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.5330
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 8
- Summaries archived here
- 8 (direct download)
- 510(k) clearances (all years, FDA)
- 57 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (8)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260709 | 2026-06-25 | Longeviti Neuro Solutions | ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm… | |
| K253116 | 2026-06-18 | The Surgeon General, Department of the… | 3D MAC Titanium Cranial Plate (TCP) System | |
| K252251 | 2026-04-09 | CG Bio Co., Ltd. | EASYMADE-TI | |
| K252958 | 2026-01-14 | Meticuly Co., Ltd. | METICULY Patient-specific titanium mesh implant | |
| K243715 | 2025-11-12 | Synthes GmbH | Synthes Patient Specific Implants | |
| K252573 | 2025-11-10 | KLS-Martin L.P. | KLS Martin Cranial Implants - MR Conditional; K94456… | |
| K240567 | 2024-03-28 | Fin-Ceramica Faenza S.P.A. | CustomizedBone Service | |
| K231920 | 2023-11-09 | Longeviti Neuro Solutions, LLC | Longeviti ClearFit OTS Cranial Implant |
Official FDA classification page: GXN
Classification and pathway per current FDA publications. Data from openFDA (CC0).