The following data is part of a premarket notification filed by Total Joint Othopedics, Inc. with the FDA for Klassic Hd Hip System.
| Device ID | K143407 |
| 510k Number | K143407 |
| Device Name: | Klassic HD Hip System |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | Total Joint Othopedics, Inc. 1567 E. Stratford Ave. Salt Lake City, UT 84106 |
| Contact | Chris Weaber |
| Correspondent | Chris Weaber Total Joint Othopedics, Inc. 1567 E. Stratford Ave. Salt Lake City, UT 84106 |
| Product Code | LZO |
| Subsequent Product Code | LPH |
| Subsequent Product Code | MBL |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-28 |
| Decision Date | 2014-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814703011658 | K143407 | 000 |
| 00814703011535 | K143407 | 000 |
| 00814703011542 | K143407 | 000 |
| 00814703011559 | K143407 | 000 |
| 00814703011566 | K143407 | 000 |
| 00814703011573 | K143407 | 000 |
| 00814703011580 | K143407 | 000 |
| 00814703011597 | K143407 | 000 |
| 00814703011603 | K143407 | 000 |
| 00814703011610 | K143407 | 000 |
| 00814703011627 | K143407 | 000 |
| 00814703011634 | K143407 | 000 |
| 00814703011641 | K143407 | 000 |
| 00814703011528 | K143407 | 000 |