K063017 is an FDA 510(k) clearance for the AESCULAP STERNUMFIX STERNAL CLOSURE SYSTEM. This device is classified as a Cerclage, Fixation (Class II - Special Controls, product code JDQ).
Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on December 27, 2006, 86 days after receiving the submission on October 2, 2006.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3010.
| 510(k) Number | K063017 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 02, 2006 |
| Decision Date | December 27, 2006 |
| Days to Decision | 86 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 |