The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Ibalance Tka System.
| Device ID | K153586 |
| 510k Number | K153586 |
| Device Name: | Arthrex IBalance TKA System |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | Arthrex, Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
| Contact | Leon Brown |
| Correspondent | Leon Brown Arthrex, Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
| Product Code | MBH |
| Subsequent Product Code | JWH |
| Subsequent Product Code | OIY |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-16 |
| Decision Date | 2016-02-19 |
| Summary: | summary |