K190069 is an FDA 510(k) clearance for the SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS). This device is classified as a Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (Class II - Special Controls, product code KTT).
Submitted by Arrowhead De, LLC (Collierville, US). The FDA issued a Cleared decision on May 14, 2019, 119 days after receiving the submission on January 15, 2019.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K190069 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 15, 2019 |
| Decision Date | May 14, 2019 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KTT - Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |