K203605 is an FDA 510(k) clearance for the SteriTrak. This device is classified as a Component, Traction, Invasive (Class II - Special Controls, product code JEC).
Submitted by Arbutus Medical, Inc. (Vancouver, CA). The FDA issued a Cleared decision on April 23, 2021, 134 days after receiving the submission on December 10, 2020.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K203605 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 10, 2020 |
| Decision Date | April 23, 2021 |
| Days to Decision | 134 days |
| Submission Type | Traditional |
| 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 |