K180582 is an FDA 510(k) clearance for the Sternal Cable System. This device is classified as a Cerclage, Fixation (Class II - Special Controls, product code JDQ).
Submitted by A & E Medical Corporation (Farmingdale, US). The FDA issued a Cleared decision on May 31, 2018, 87 days after receiving the submission on March 5, 2018.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3010.
| 510(k) Number | K180582 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 05, 2018 |
| Decision Date | May 31, 2018 |
| 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 |