K924099 is an FDA 510(k) clearance for the UFC HIP STEM COMPONENT. This device is classified as a Prosthesis, Hip, Femoral Component, Cemented, Metal (Class II - Special Controls, product code JDG).
Submitted by Implantology Corp. (Pine Brook, US). The FDA issued a Cleared decision on April 30, 1993, 260 days after receiving the submission on August 13, 1992.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3360.
| 510(k) Number | K924099 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 13, 1992 |
| Decision Date | April 30, 1993 |
| Days to Decision | 260 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | JDG — Prosthesis, Hip, Femoral Component, Cemented, Metal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3360 |