K143661 is an FDA 510(k) clearance for the DirectInject. This device is classified as a Methyl Methacrylate For Cranioplasty (Class II - Special Controls, product code GXP).
Submitted by Stryker (Portage, US). The FDA issued a Cleared decision on September 2, 2015, 253 days after receiving the submission on December 23, 2014.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5300.
| 510(k) Number | K143661 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2014 |
| Decision Date | September 02, 2015 |
| Days to Decision | 253 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXP — Methyl Methacrylate For Cranioplasty |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5300 |