The following data is part of a premarket notification filed by Turnkey Intergration Usa, Inc. with the FDA for Artos, Diplos System.
| Device ID | K970284 |
| 510k Number | K970284 |
| Device Name: | ARTOS, DIPLOS SYSTEM |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Applicant | TURNKEY INTERGRATION USA, INC. 962 S. TAMIAMI TRAIL SUITE 203 Sarasota, FL 34326 |
| Product Code | KWY |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-24 |
| Decision Date | 1997-04-21 |