The following data is part of a premarket notification filed by Stelkast Company with the FDA for Proform General Application Cemented Femoral Component.
| Device ID | K970490 |
| 510k Number | K970490 |
| Device Name: | PROFORM GENERAL APPLICATION CEMENTED FEMORAL COMPONENT |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| 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 | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-10 |
| Decision Date | 1997-05-02 |