K240137 is an FDA 510(k) clearance for the Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System. This device is classified as a Cover, Burr Hole (Class II - Special Controls, product code GXR).
Submitted by Neos Surgery S.L (Cerdanyola, ES). The FDA issued a Cleared decision on February 16, 2024, 29 days after receiving the submission on January 18, 2024.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5250.
| 510(k) Number | K240137 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 18, 2024 |
| Decision Date | February 16, 2024 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXR - Cover, Burr Hole |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5250 |