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 |