The following data is part of a premarket notification filed by In2bones Sas with the FDA for Triway Tibiotalocalcaneal (ttc) Arthrodesis System.
| Device ID | K173811 |
| 510k Number | K173811 |
| Device Name: | TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | In2Bones SAS 28 Chemin Du Petit Bois Ecully, FR 69130 |
| Contact | Morgane Grenier |
| Correspondent | Christine Scifert MRC-X, LLC 6075 Poplar Avenue, Suite 500 N Memphis, TN 38119 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-15 |
| Decision Date | 2018-03-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760225717615 | K173811 | 000 |
| 03760225717820 | K173811 | 000 |
| 03760225717813 | K173811 | 000 |
| 03760225717806 | K173811 | 000 |
| 03760225717790 | K173811 | 000 |
| 03760225717783 | K173811 | 000 |
| 03760225717776 | K173811 | 000 |
| 03760225717769 | K173811 | 000 |
| 03760225717752 | K173811 | 000 |
| 03760225717745 | K173811 | 000 |
| 03760225717738 | K173811 | 000 |
| 03760225717721 | K173811 | 000 |
| 03760225717714 | K173811 | 000 |
| 03760225717707 | K173811 | 000 |
| 03760225717691 | K173811 | 000 |
| 03760225717684 | K173811 | 000 |
| 03760225717837 | K173811 | 000 |
| 03760225717844 | K173811 | 000 |
| 03760225717585 | K173811 | 000 |
| 03760225717660 | K173811 | 000 |
| 03760225717653 | K173811 | 000 |
| 03760225717646 | K173811 | 000 |
| 03760225717639 | K173811 | 000 |
| 03760225717622 | K173811 | 000 |
| 03760225717592 | K173811 | 000 |
| 03760225717578 | K173811 | 000 |
| 03760225717561 | K173811 | 000 |
| 03760225717554 | K173811 | 000 |
| 03760225717547 | K173811 | 000 |
| 03760225717530 | K173811 | 000 |
| 03760225717523 | K173811 | 000 |
| 03760225717509 | K173811 | 000 |
| 03760225717493 | K173811 | 000 |
| 03760225717677 | K173811 | 000 |