K193029 is an FDA 510(k) clearance for the CONQUEST FN. 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 February 28, 2020, 121 days after receiving the submission on October 30, 2019.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K193029 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 30, 2019 |
| Decision Date | February 28, 2020 |
| Days to Decision | 121 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 |