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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue
510(k) Number K190774
Device Name RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL Implant
Applicant
Medos International SARL
Chemin-Blanc 38
Le Locle,  CH 2400
Applicant Contact LeeAnn Walosin
Correspondent
DePuy Mitek, Inc.
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact LeeAnn Walosin
Regulation Number888.3040
Classification Product Code
MBI  
Subsequent Product Code
HTN  
Date Received03/26/2019
Decision Date 07/25/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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