The following data is part of a premarket notification filed by Stelkast Company with the FDA for Proform Cemented Femoral Component.
| Device ID | K951083 |
| 510k Number | K951083 |
| Device Name: | PROFORM CEMENTED FEMORAL COMPONENT |
| Classification | Prosthesis, Hip, Femoral Component, Cemented, Metal |
| Applicant | STELKAST COMPANY 800 VINIAL ST. SUITE B-210 Pittsburgh, PA 15212 |
| Contact | Donald A Stevens |
| Correspondent | Donald A Stevens STELKAST COMPANY 800 VINIAL ST. SUITE B-210 Pittsburgh, PA 15212 |
| Product Code | JDG |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-09 |
| Decision Date | 1995-05-22 |