K173499 is an FDA 510(k) clearance for the Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads. This device is classified as a Prosthesis, Hip, Femoral Component, Cemented, Metal (Class II - Special Controls, product code JDG).
Submitted by Stryker Orthopaedics (Mahwah, US). The FDA issued a Cleared decision on March 19, 2018, 126 days after receiving the submission on November 13, 2017.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3360.
| 510(k) Number | K173499 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 2017 |
| Decision Date | March 19, 2018 |
| Days to Decision | 126 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDG — Prosthesis, Hip, Femoral Component, Cemented, Metal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3360 |