The following data is part of a premarket notification filed by Turnkey Intergration Usa, Inc. with the FDA for Omni-fix, Humeral Nail.
| Device ID | K991405 |
| 510k Number | K991405 |
| Device Name: | OMNI-FIX, HUMERAL NAIL |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Single Component |
| Applicant | TURNKEY INTERGRATION USA, INC. 962 SOUTH TAMIAMI TRAIL, SUITE 203 Sarasota, FL 34326 |
| Contact | Douglas W Stuart |
| Correspondent | Douglas W Stuart TURNKEY INTERGRATION USA, INC. 962 SOUTH TAMIAMI TRAIL, SUITE 203 Sarasota, FL 34326 |
| Product Code | KTW |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-22 |
| Decision Date | 1999-06-29 |
| Summary: | summary |