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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name plate, fixation, bone
510(k) Number K173121
Device Name Ankle Fusion Plating System
In2Bones SAS
28 Chemin du Petit Bois
ecully,  FR 69130
Applicant Contact morgane grenier
6075 Poplar Ave
Suite 500
memphis,  TN  38119
Correspondent Contact christine scifert
Regulation Number888.3030
Classification Product Code
Subsequent Product Code
Date Received09/29/2017
Decision Date 11/28/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No