K031162 is an FDA 510(k) clearance for the SMITH & NEPHEW ORTHOPAEDIC CABLING SYSTEM. This device is classified as a Cerclage, Fixation (Class II - Special Controls, product code JDQ).
Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on May 1, 2003, 17 days after receiving the submission on April 14, 2003.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3010.
| 510(k) Number | K031162 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 14, 2003 |
| Decision Date | May 01, 2003 |
| Days to Decision | 17 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDQ — Cerclage, Fixation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3010 |