The following data is part of a premarket notification filed by Turnkey Intergration Usa, Inc. with the FDA for C-fit Cemented Hip Stem.
| Device ID | K923898 |
| 510k Number | K923898 |
| Device Name: | C-FIT CEMENTED HIP STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | TURNKEY INTERGRATION USA, INC. 8021 KNUE RD. SUITE 121 Indianapolis, IN 46250 |
| Contact | D. W Stuart |
| Correspondent | D. W Stuart TURNKEY INTERGRATION USA, INC. 8021 KNUE RD. SUITE 121 Indianapolis, IN 46250 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-04 |
| Decision Date | 1992-11-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051693301085 | K923898 | 000 |
| 05051693300439 | K923898 | 000 |
| 05051693300422 | K923898 | 000 |
| 05051693300415 | K923898 | 000 |
| 05051693300408 | K923898 | 000 |
| 05051693300392 | K923898 | 000 |
| 05051693300385 | K923898 | 000 |
| 05051693300378 | K923898 | 000 |
| 05051693300361 | K923898 | 000 |
| 05051693300354 | K923898 | 000 |
| 05051693300347 | K923898 | 000 |
| 05051693300446 | K923898 | 000 |
| 05051693300972 | K923898 | 000 |
| 05051693301078 | K923898 | 000 |
| 05051693301061 | K923898 | 000 |
| 05051693301054 | K923898 | 000 |
| 05051693301047 | K923898 | 000 |
| 05051693301030 | K923898 | 000 |
| 05051693301023 | K923898 | 000 |
| 05051693301016 | K923898 | 000 |
| 05051693301009 | K923898 | 000 |
| 05051693300996 | K923898 | 000 |
| 05051693300989 | K923898 | 000 |
| 05051693300330 | K923898 | 000 |