The following data is part of a premarket notification filed by Colmed, Ltd. with the FDA for Charnley Design Hip Prosthesis.
| Device ID | K801006 |
| 510k Number | K801006 |
| Device Name: | CHARNLEY DESIGN HIP PROSTHESIS |
| Classification | Prosthesis, Hip, Femoral Component, Cemented, Metal |
| Applicant | COLMED, LTD. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JDG |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-04-28 |
| Decision Date | 1980-05-20 |