The following data is part of a premarket notification filed by Turnkey Intergration Usa, Inc. with the FDA for Link Cerclage Wire System.
| Device ID | K970084 |
| 510k Number | K970084 |
| Device Name: | LINK CERCLAGE WIRE SYSTEM |
| Classification | Cerclage, Fixation |
| 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 | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-09 |
| Decision Date | 1997-03-13 |