The following data is part of a premarket notification filed by Total Joint Orthopedics, Inc. with the FDA for Klassic Knee System.
| Device ID | K153310 |
| 510k Number | K153310 |
| 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 | 2015-11-17 |
| Decision Date | 2015-12-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814703012549 | K153310 | 000 |
| 00814703016691 | K153310 | 000 |