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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 K183279
Device Name HEALIX Ti ANCHOR with DYNACORD
Applicant
Medos International SARL
Chemin-Blanc 38, Case Postale
Le Locle,  CH Ch 2400
Applicant Contact N/A N/A
Correspondent
Depuy Mitek, A Johnson and Johnson Company
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact Leslie Coney
Regulation Number888.3040
Classification Product Code
MBI  
Subsequent Product Code
HWC  
Date Received11/23/2018
Decision Date 02/21/2019
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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