The following data is part of a premarket notification filed by Stelkast, Inc. with the FDA for Genflex2 Total Knee System.
| Device ID | K162222 |
| 510k Number | K162222 |
| Device Name: | GENflex2 Total Knee System |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | StelKast, Inc. 200 Hidden Valley Road Mcmurray, PA 15317 |
| Contact | Dave Stumpo |
| Correspondent | David Stumpo StelKast, Inc. 200 Hidden Valley Road 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 | 2016-08-08 |
| Decision Date | 2016-09-07 |
| Summary: | summary |