The following data is part of a premarket notification filed by Total Joint Orthopedics, Inc. with the FDA for Klassic Femur, Porous, Klassic Tibial Baseplate, Porous.
| Device ID | K162256 |
| 510k Number | K162256 |
| Device Name: | Klassic Femur, Porous, Klassic Tibial Baseplate, Porous |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, 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 | MBH |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-11 |
| Decision Date | 2016-10-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814703013522 | K162256 | 000 |
| 00814703016721 | K162256 | 000 |
| 00814703016738 | K162256 | 000 |
| 00814703016745 | K162256 | 000 |
| 00814703016752 | K162256 | 000 |
| 00814703016769 | K162256 | 000 |
| 00814703013409 | K162256 | 000 |
| 00814703013416 | K162256 | 000 |
| 00814703013423 | K162256 | 000 |
| 00814703013430 | K162256 | 000 |
| 00814703013447 | K162256 | 000 |
| 00814703013454 | K162256 | 000 |
| 00814703013461 | K162256 | 000 |
| 00814703013478 | K162256 | 000 |
| 00814703013485 | K162256 | 000 |
| 00814703013492 | K162256 | 000 |
| 00814703013508 | K162256 | 000 |
| 00814703013515 | K162256 | 000 |
| 00814703016714 | K162256 | 000 |