The following data is part of a premarket notification filed by Total Joint Orthopedics, Inc. with the FDA for Klassic Knee System.
| Device ID | K162422 |
| 510k Number | K162422 |
| Device Name: | Klassic Knee System |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | Total Joint Orthopedics, Inc. 1567 E. Stratford Avenue Salt Lake City, UT 84106 |
| Contact | Chris Weaber |
| Correspondent | Chris Weaber Total Joint Orthopedics, Inc. 1567 E. Stratford Avenue Salt Lake City, UT 84106 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-30 |
| Decision Date | 2016-10-28 |
| Summary: | summary |