GXP
- Product code
- GXP
- Device name
- Methyl Methacrylate For Cranioplasty
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.5300
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 45
510(k) clearances, last 3 years (7)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251959 | 2026-07-30 | T&R BIOFAB CO., Ltd. | TnR Cranial Implant | |
| K261265 | 2026-06-15 | Orthocon, Inc. | Permatage XT Settable Bone Putty | |
| K253732 | 2026-03-13 | Orthocon, Inc. | Permatage Flowable, Settable Bone Paste | |
| K253854 | 2026-01-02 | Orthocon, Inc. | MONTAGE XT Cranial Cement | |
| K241027 | 2024-09-26 | Orthocon, Inc. | Permatage Settable Bone Putty | |
| K232771 | 2024-02-16 | Orthocon, Inc. | Montage Flowable Settable, Resorbable Bone Paste | |
| K231475 | 2023-10-12 | Orthocon, Inc. | MONTAGE-QS Settable, Resorbable Bone Putty |
Official FDA classification page: GXP
Classification and pathway per current FDA publications. Data from openFDA (CC0).