K240137
- 510(k) number
- K240137
- Device name
- Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System
- Applicant
- Neos Surgery S.L ES
- Product code
- GXR — Cover, Burr Hole
- Decision date
- 2024-02-16
- Date received
- 2024-01-18
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
510(k) Summary (official FDA PDF): K240137.pdf
Official FDA record: K240137
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.