K193616 is an FDA 510(k) clearance for the ARIX Ankle System. This device is classified as a Plate, Fixation, Bone (Class II - Special Controls, product code HRS).
Submitted by Jeil Medical Corporation (Seoul, KR). The FDA issued a Cleared decision on March 4, 2020, 69 days after receiving the submission on December 26, 2019.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K193616 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 26, 2019 |
| Decision Date | March 04, 2020 |
| Days to Decision | 69 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HRS — Plate, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |