K211613 is an FDA 510(k) clearance for the Stern Fix Sternal Stabilization System. This device is classified as a Cerclage, Fixation (Class II - Special Controls, product code JDQ).
Submitted by Neos Surgery S.L (Barcelona, ES). The FDA issued a Cleared decision on January 19, 2022, 238 days after receiving the submission on May 26, 2021.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3010.
| 510(k) Number | K211613 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 26, 2021 |
| Decision Date | January 19, 2022 |
| Days to Decision | 238 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 |