K151387 is an FDA 510(k) clearance for the Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade. This device is classified as a Fastener, Plate, Cranioplasty (Class II - Special Controls, product code HBW).
Submitted by Stryker (Portage, US). The FDA issued a Cleared decision on June 24, 2015, 29 days after receiving the submission on May 26, 2015.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5360.
| 510(k) Number | K151387 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 26, 2015 |
| Decision Date | June 24, 2015 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HBW — Fastener, Plate, Cranioplasty |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5360 |