K101235 is an FDA 510(k) clearance for the CRANIAL LOOP 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 (Alexandria, US). The FDA issued a Cleared decision on October 25, 2010, 175 days after receiving the submission on May 3, 2010.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5250.
| 510(k) Number | K101235 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 03, 2010 |
| Decision Date | October 25, 2010 |
| Days to Decision | 175 days |
| Submission Type | Traditional |
| 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 |