K202016 is an FDA 510(k) clearance for the Dall-Miles® Cable System. This device is classified as a Cerclage, Fixation (Class II - Special Controls, product code JDQ).
Submitted by Howmedica Osteonics Corp., Dba Stryker Orthopaedics (Mahwah, US). The FDA issued a Cleared decision on October 16, 2020, 87 days after receiving the submission on July 21, 2020.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3010.
| 510(k) Number | K202016 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 21, 2020 |
| Decision Date | October 16, 2020 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDQ — Cerclage, Fixation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3010 |