The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Ibalance Tka System.
| Device ID | K133342 |
| 510k Number | K133342 |
| Device Name: | ARTHREX IBALANCE TKA SYSTEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
| Contact | Mariela Cabarcas |
| Correspondent | Mariela Cabarcas ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-30 |
| Decision Date | 2013-12-17 |
| Summary: | summary |