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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 K172485
Device Name Footmotion HammerToe
Applicant
Newclip Technics
PA de la Lande Saint Martin - 45 rue des Garottieres
Haute-Goulaine,  FR 44 115
Applicant Contact Gaelle Lussori
Correspondent
The OrthoMedix Group, Inc.
1001 Oakwood Blvd
Round Rock,  TX  78681
Correspondent Contact J.D. Webb
Regulation Number888.3040
Classification Product Code
HTY  
Date Received08/17/2017
Decision Date 03/02/2018
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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