K130447 is an FDA 510(k) clearance for the SPEEDY FLAP SYSTEM. This device is classified as a Plate, Cranioplasty, Preformed, Non-alterable (Class II - Special Controls, product code GXN).
Submitted by Jeil Medical Corporation (Seoul, KR). The FDA issued a Cleared decision on December 22, 2014, 669 days after receiving the submission on February 21, 2013.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5330.
| 510(k) Number | K130447 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 21, 2013 |
| Decision Date | December 22, 2014 |
| Days to Decision | 669 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXN — Plate, Cranioplasty, Preformed, Non-alterable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5330 |