The following data is part of a premarket notification filed by Stelkast Company with the FDA for Progeny Forged Cocr Cemented Femoral Component.
| Device ID | K001984 |
| 510k Number | K001984 |
| Device Name: | PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT |
| Classification | Prosthesis, Hip, Femoral Component, Cemented, Metal |
| Applicant | STELKAST COMPANY 800 VINIAL ST. #210 Pittsburgh, PA 15212 |
| Contact | Donald A Stevens |
| Correspondent | Donald A Stevens STELKAST COMPANY 800 VINIAL ST. #210 Pittsburgh, PA 15212 |
| Product Code | JDG |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-29 |
| Decision Date | 2000-09-27 |