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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 K161001
Device Name MILAGRO ADVANCE PEEK Interference Screw
Applicant
Medos International SARL
Chemin-Blanc 38, Case Postale
Le Locle,  CH Ch 2400
Applicant Contact Kristine Christo
Correspondent
Depuy Mitek, Inc., A Johnson and Johnson Company
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact Kristine Christo
Regulation Number888.3040
Classification Product Code
MBI  
Date Received04/11/2016
Decision Date 06/09/2016
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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