The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Ibalance Bicompartmental Arthroplasty System.
| Device ID | K160461 |
| 510k Number | K160461 |
| Device Name: | Arthrex IBalance BiCompartmental Arthroplasty System |
| Classification | Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer |
| Applicant | Arthrex, Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
| Contact | Courtney Smith |
| Correspondent | Courtney Smith Arthrex, Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
| Product Code | KRR |
| CFR Regulation Number | 888.3540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-19 |
| Decision Date | 2016-04-12 |
| Summary: | summary |