The following data is part of a premarket notification filed by Arthrex Inc. with the FDA for Ibalance Uka Tibial Tray Implant.
| Device ID | K200433 |
| 510k Number | K200433 |
| Device Name: | IBalance UKA Tibial Tray Implant |
| Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
| Applicant | Arthrex Inc. 1370 Creekside Boulevard Naples, FL 34108 |
| Contact | Ivette Galmez |
| Correspondent | Ivette Galmez Arthrex Inc. 1370 Creekside Boulevard Naples, FL 34108 |
| Product Code | HSX |
| CFR Regulation Number | 888.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-21 |
| Decision Date | 2020-03-17 |