The following data is part of a premarket notification filed by Mako Surgical with the FDA for Kinetis Total Knee System.
| Device ID | K143635 |
| 510k Number | K143635 |
| Device Name: | KINETIS Total Knee System |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | MAKO SURGICAL 2555 DAVIE RD. Ft. Lauderdale, FL 33317 |
| Contact | Jonathan Reeves |
| Correspondent | Jonathan Reeves MAKO SURGICAL 2555 DAVIE RD. Ft. Lauderdale, FL 33317 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-22 |
| Decision Date | 2015-02-20 |
| Summary: | summary |