The following data is part of a premarket notification filed by Stelkast Company with the FDA for Proven Modular Posterior Stabilized Femoral.
| Device ID | K021908 |
| 510k Number | K021908 |
| Device Name: | PROVEN MODULAR POSTERIOR STABILIZED FEMORAL |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | STELKAST COMPANY 200 HIDDEN VALLEY RD. Mcmurray, PA 15317 |
| Contact | Donald A Stevens |
| Correspondent | Donald A Stevens STELKAST COMPANY 200 HIDDEN VALLEY RD. Mcmurray, PA 15317 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-10 |
| Decision Date | 2002-07-09 |