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)
- 3
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 29 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253447 | 2026-03-16 | Orthocon, Inc. | Montage Flowable Settable, Resorbable Bone Paste (Bu… | |
| K240137 | 2024-02-16 | Neos Surgery S.L | Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cra… | FDA |
| K221606 | 2023-11-21 | Chendu Medart Medical Scientific Co., … | Absorbable Cranial Flap Fixation System |
Official FDA classification page: GXR
Classification and pathway per current FDA publications. Data from openFDA (CC0).