K122225 is an FDA 510(k) clearance for the STERILE RADIOLUCENT SKULL PINS. This device is classified as a Holder, Head, Neurosurgical (skull Clamp) (Class II - Special Controls, product code HBL).
Submitted by Brainlab AG (Feldkirchen, DE). The FDA issued a Cleared decision on April 26, 2013, 275 days after receiving the submission on July 25, 2012.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4460.
| 510(k) Number | K122225 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 25, 2012 |
| Decision Date | April 26, 2013 |
| Days to Decision | 275 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HBL — Holder, Head, Neurosurgical (skull Clamp) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4460 |