K780357 is an FDA 510(k) clearance for the TITANIUM MULLER TOTAL HIP. This device is classified as a Prosthesis, Hip, Femoral Component, Cemented, Metal (Class II - Special Controls, product code JDG).
Submitted by Biomet, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 5, 1978, 30 days after receiving the submission on March 6, 1978.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3360.
| 510(k) Number | K780357 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 1978 |
| Decision Date | April 05, 1978 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | JDG — Prosthesis, Hip, Femoral Component, Cemented, Metal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3360 |