The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Ibalance Uka System Vitamin E Tibial Bearing.
| Device ID | K161060 |
| 510k Number | K161060 |
| Device Name: | Arthrex IBalance UKA System Vitamin E Tibial Bearing |
| Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
| Applicant | Arthrex, Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
| Contact | David L Rogers |
| Correspondent | David L Rogers Arthrex, Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
| Product Code | HSX |
| CFR Regulation Number | 888.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-15 |
| Decision Date | 2016-12-15 |
| Summary: | summary |