The following data is part of a premarket notification filed by Total Joint Orthopedics, Inc. with the FDA for Klassic Knee Tibial Stem Extension.
| Device ID | K140942 |
| 510k Number | K140942 |
| Device Name: | KLASSIC KNEE TIBIAL STEM EXTENSION |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | TOTAL JOINT ORTHOPEDICS, INC. 1567 E. STRATFORD AVE. Salt Lake City, UT 84106 |
| Contact | Jean Wheeler |
| Correspondent | Jean Wheeler TOTAL JOINT ORTHOPEDICS, INC. 1567 E. STRATFORD AVE. Salt Lake City, UT 84106 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-14 |
| Decision Date | 2014-05-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814703011511 | K140942 | 000 |
| 00814703011504 | K140942 | 000 |
| 00814703011498 | K140942 | 000 |
| 00814703011481 | K140942 | 000 |
| 00814703011474 | K140942 | 000 |
| 00814703011467 | K140942 | 000 |