K080434 is an FDA 510(k) clearance for the INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW. This device is classified as a Device, Fixation, Proximal Femoral, Implant (Class II - Special Controls, product code JDO).
Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on April 10, 2008, 51 days after receiving the submission on February 19, 2008.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K080434 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 19, 2008 |
| Decision Date | April 10, 2008 |
| Days to Decision | 51 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDO — Device, Fixation, Proximal Femoral, Implant |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |