The following data is part of a premarket notification filed by Stelkast Company with the FDA for Stelkast Proven Cemented, Semi-constrained Total Knee System.
| Device ID | K980276 |
| 510k Number | K980276 |
| Device Name: | STELKAST PROVEN CEMENTED, SEMI-CONSTRAINED TOTAL KNEE SYSTEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| 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 | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-26 |
| Decision Date | 1998-04-24 |