The following data is part of a premarket notification filed by Stelkast Company with the FDA for Stelkast Unicondylar Knee System.
| Device ID | K032824 |
| 510k Number | K032824 |
| Device Name: | STELKAST UNICONDYLAR KNEE SYSTEM |
| Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
| Applicant | STELKAST COMPANY 200 HIDDEN VALLEY ROAD Mcmurray, PA 15317 |
| Contact | Donald Stevens |
| Correspondent | Donald Stevens STELKAST COMPANY 200 HIDDEN VALLEY ROAD Mcmurray, PA 15317 |
| Product Code | HSX |
| CFR Regulation Number | 888.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-10 |
| Decision Date | 2003-11-13 |