K141644 is an FDA 510(k) clearance for the INNOVASIS CRANIAL SYSTEM. This device is classified as a Plate, Cranioplasty, Preformed, Alterable (Class II - Special Controls, product code GWO).
Submitted by Innovasis, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on November 7, 2014, 141 days after receiving the submission on June 19, 2014.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5320.
| 510(k) Number | K141644 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 19, 2014 |
| Decision Date | November 07, 2014 |
| Days to Decision | 141 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GWO — Plate, Cranioplasty, Preformed, Alterable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5320 |