K945783 is an FDA 510(k) clearance for the ORTHOMET TITANIUM HYBRID FEMORAL STEM. This device is classified as a Prosthesis, Hip, Femoral Component, Cemented, Metal (Class II - Special Controls, product code JDG).
Submitted by Orthomet, Inc. (Minneapolis, US). The FDA issued a Cleared decision on May 30, 1995, 186 days after receiving the submission on November 25, 1994.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3360.
| 510(k) Number | K945783 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 25, 1994 |
| Decision Date | May 30, 1995 |
| Days to Decision | 186 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 |