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 |
---|---|---|
03701337615581 | K173811 | 000 |
03760225717714 | K173811 | 000 |
03760225717721 | K173811 | 000 |
03760225717738 | K173811 | 000 |
03760225717745 | K173811 | 000 |
03760225717752 | K173811 | 000 |
03760225717769 | K173811 | 000 |
03760225717776 | K173811 | 000 |
03760225717783 | K173811 | 000 |
03760225717707 | K173811 | 000 |
03760225717691 | K173811 | 000 |
03701337615598 | K173811 | 000 |
03701337615604 | K173811 | 000 |
03701337615611 | K173811 | 000 |
03701337615628 | K173811 | 000 |
03701337615635 | K173811 | 000 |
03701337615642 | K173811 | 000 |
03760225717677 | K173811 | 000 |
03760225717684 | K173811 | 000 |
03760225717790 | K173811 | 000 |
03760225717806 | K173811 | 000 |
03760225717813 | K173811 | 000 |
03760225717578 | K173811 | 000 |
03760225717592 | K173811 | 000 |
03760225717622 | K173811 | 000 |
03760225717639 | K173811 | 000 |
03760225717646 | K173811 | 000 |
03760225717653 | K173811 | 000 |
03760225717660 | K173811 | 000 |
03760225717585 | K173811 | 000 |
03760225717561 | K173811 | 000 |
03760225717554 | K173811 | 000 |
03760225717820 | K173811 | 000 |
03760225717837 | K173811 | 000 |
03760225717844 | K173811 | 000 |
03760225717493 | K173811 | 000 |
03760225717509 | K173811 | 000 |
03760225717523 | K173811 | 000 |
03760225717530 | K173811 | 000 |
03760225717547 | K173811 | 000 |
03760225717615 | K173811 | 000 |