The following data is part of a premarket notification filed by Stelkast Company with the FDA for Proven Knee System High Flexion Tibial Insert.
| Device ID | K063211 |
| 510k Number | K063211 |
| Device Name: | PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | STELKAST COMPANY 200 HIDDEN VALLEY RD. Mcmurray, PA 15317 |
| Contact | David J Stumpo |
| Correspondent | David J Stumpo STELKAST COMPANY 200 HIDDEN VALLEY RD. Mcmurray, PA 15317 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-23 |
| Decision Date | 2007-01-18 |
| Summary: | summary |