The following data is part of a premarket notification filed by Total Joint Orthopedics with the FDA for Klassic Bipolar System.
| Device ID | K143113 |
| 510k Number | K143113 |
| Device Name: | Klassic BiPolar System |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Applicant | Total Joint Orthopedics 1567 E. Stratford Avenue Salt Lake City, UT 84106 |
| Contact | Chris Weaber |
| Correspondent | Chris Weaber Total Joint Orthopedics 1567 E. Stratford Avenue Salt Lake City, UT 84106 |
| Product Code | KWY |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-30 |
| Decision Date | 2015-01-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814703012198 | K143113 | 000 |
| 00814703012037 | K143113 | 000 |
| 00814703012020 | K143113 | 000 |
| 00814703012013 | K143113 | 000 |
| 00814703012006 | K143113 | 000 |
| 00814703011993 | K143113 | 000 |
| 00814703011986 | K143113 | 000 |
| 00814703011979 | K143113 | 000 |
| 00814703011962 | K143113 | 000 |
| 00814703011955 | K143113 | 000 |
| 00814703011948 | K143113 | 000 |
| 00814703011931 | K143113 | 000 |
| 00814703011924 | K143113 | 000 |
| 00814703011917 | K143113 | 000 |
| 00814703012044 | K143113 | 000 |
| 00814703012051 | K143113 | 000 |
| 00814703012181 | K143113 | 000 |
| 00814703012174 | K143113 | 000 |
| 00814703012167 | K143113 | 000 |
| 00814703012150 | K143113 | 000 |
| 00814703012143 | K143113 | 000 |
| 00814703012136 | K143113 | 000 |
| 00814703012129 | K143113 | 000 |
| 00814703012112 | K143113 | 000 |
| 00814703012105 | K143113 | 000 |
| 00814703012099 | K143113 | 000 |
| 00814703012082 | K143113 | 000 |
| 00814703012075 | K143113 | 000 |
| 00814703012068 | K143113 | 000 |
| 00814703011900 | K143113 | 000 |