K133785 is an FDA 510(k) clearance for the TRITIUM STERNAL CABLE PLATE SYSTEM. This device is classified as a Cerclage, Fixation (Class II - Special Controls, product code JDQ).
Submitted by Pioneer Surgical Technology, Inc. (Marquette, US). The FDA issued a Cleared decision on January 27, 2014, 46 days after receiving the submission on December 12, 2013.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3010.
| 510(k) Number | K133785 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 12, 2013 |
| Decision Date | January 27, 2014 |
| Days to Decision | 46 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 |