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 |