K761002 is an FDA 510(k) clearance for the CHARNLEY CONGENITAL HIP FEMUR (85-3060). This device is classified as a Prosthesis, Hip, Femoral Component, Cemented, Metal (Class II - Special Controls, product code JDG).
Submitted by Codman & Shurtleff, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 23, 1976, 15 days after receiving the submission on November 8, 1976.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3360.
| 510(k) Number | K761002 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 1976 |
| Decision Date | November 23, 1976 |
| Days to Decision | 15 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 |