The following data is part of a premarket notification filed by In2bones Sas with the FDA for Dip Arthrodesis System.
Device ID | K173616 |
510k Number | K173616 |
Device Name: | DIP Arthrodesis System |
Classification | Pin, Fixation, Smooth |
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 Memphis, TN 38119 |
Product Code | HTY |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-11-22 |
Decision Date | 2018-01-19 |
Summary: | summary |