K915581 is an FDA 510(k) clearance for the CODMAN SOF'WIRE (TM) KIT. This device is classified as a Cerclage, Fixation (Class II - Special Controls, product code JDQ).
Submitted by Codman & Shurtleff, Inc. (Randolph, US). The FDA issued a Cleared decision on January 16, 1992, 34 days after receiving the submission on December 13, 1991.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3010.
| 510(k) Number | K915581 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 13, 1991 |
| Decision Date | January 16, 1992 |
| Days to Decision | 34 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 |