GXR
- Product code
- GXR
- Device name
- Cover, Burr Hole
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.5250
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 29
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name |
|---|---|---|---|
| K253447 | 2026-03-16 | Orthocon, Inc. | Montage Flowable Settable, Resorbable Bone Paste (Bu summary |
| K240137 | 2024-02-16 | Neos Surgery S.L | Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cra summary |
| K221606 | 2023-11-21 | Chendu Medart Medical Scientific Co., | Absorbable Cranial Flap Fixation System summary |
Official FDA classification page: GXR
Classification and pathway per current FDA publications. Data from openFDA (CC0).