The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Ibalance Tka System.
| Device ID | K152252 |
| 510k Number | K152252 |
| Device Name: | Arthrex IBalance TKA System |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | ARTHREX, INC. 1370 CREEKSIDE BLVD Naples, FL 34108 -1945 |
| Contact | Leon Brown |
| Correspondent | Leon Brown ARTHREX, INC. 1370 CREEKSIDE BLVD Naples, FL 34108 -1945 |
| Product Code | MBH |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-10 |
| Decision Date | 2015-11-16 |
| Summary: | summary |