K192465 is an FDA 510(k) clearance for the DigiFix Sterile Kit. This device is classified as a Component, Traction, Invasive (Class II - Special Controls, product code JEC).
Submitted by Virak Orthopedics, LLC (Harrison, US). The FDA issued a Cleared decision on October 10, 2019, 31 days after receiving the submission on September 9, 2019.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K192465 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 2019 |
| Decision Date | October 10, 2019 |
| Days to Decision | 31 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JEC - Component, Traction, Invasive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |