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 | K161073 |
| 510k Number | K161073 |
| Device Name: | Klassic HD Hip System |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | Total Joint Othopedics, Inc. 1567 E. Stratford Avenue Salt Lake City, UT 84106 |
| Contact | Chris Weaber |
| Correspondent | Chris Weaber Total Joint Othopedics, Inc. 1567 E. Stratford Avenue Salt Lake City, UT 84106 |
| Product Code | LPH |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | LZO |
| Subsequent Product Code | MBL |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-18 |
| Decision Date | 2016-10-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814703012914 | K161073 | 000 |
| 00814703012778 | K161073 | 000 |
| 00814703012785 | K161073 | 000 |
| 00814703012792 | K161073 | 000 |
| 00814703012808 | K161073 | 000 |
| 00814703012815 | K161073 | 000 |
| 00814703012822 | K161073 | 000 |
| 00814703012839 | K161073 | 000 |
| 00814703012846 | K161073 | 000 |
| 00814703012853 | K161073 | 000 |
| 00814703012860 | K161073 | 000 |
| 00814703012877 | K161073 | 000 |
| 00814703012884 | K161073 | 000 |
| 00814703012891 | K161073 | 000 |
| 00814703012907 | K161073 | 000 |
| 00814703012761 | K161073 | 000 |