The following data is part of a premarket notification filed by Total Joint Orthopedics, Inc. with the FDA for Klassic Knee System - Sombrero Patella With Standard Poly, Klassic Knee System - Sombrero Patella With E-link Poly.
| Device ID | K190280 |
| 510k Number | K190280 |
| Device Name: | Klassic Knee System - Sombrero Patella With Standard Poly, Klassic Knee System - Sombrero Patella With E-Link Poly |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | Total Joint Orthopedics, Inc. 1567 East Stratford Avenue Salt Lake City, UT 84106 |
| Contact | Chris Weaber |
| Correspondent | Chris Weaber Total Joint Orthopedics, Inc. 1567 East Stratford Avenue Salt Lake City, UT 84106 |
| Product Code | JWH |
| Subsequent Product Code | MBH |
| Subsequent Product Code | OIY |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-08 |
| Decision Date | 2019-03-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814703016783 | K190280 | 000 |
| 00814703016776 | K190280 | 000 |