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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pin, fixation, smooth
510(k) Number K173616
Device Name DIP Arthrodesis System
Applicant
In2Bones SAS
28 Chemin du Petit Bois
Ecully,  FR 69130
Applicant Contact Morgane Grenier
Correspondent
MRC-X, LLC
6075 Poplar Avenue
Suite 500
Memphis,  TN  38119
Correspondent Contact Christine Scifert
Regulation Number888.3040
Classification Product Code
HTY  
Date Received11/22/2017
Decision Date 01/19/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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