K103797 is an FDA 510(k) clearance for the K2M COCR WIRE. This device is classified as a Cerclage, Fixation (Class II - Special Controls, product code JDQ).
Submitted by K2m, Inc. (Leesburg, US). The FDA issued a Cleared decision on May 20, 2011, 144 days after receiving the submission on December 27, 2010.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3010.
| 510(k) Number | K103797 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 2010 |
| Decision Date | May 20, 2011 |
| Days to Decision | 144 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 |