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 |