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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 K200949
Device Name HEALIX ADVANCE Anchor with DYNATAPE Suture
Applicant
Medos International SARL
Chemin-Blanc 38, Case Postale
Le Locle,  CH Ch 2400
Applicant Contact Elizabeth Messana
Correspondent
Depuy Synthesmitek, A Johnson and Johnson Company
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact Elizabeth Messana
Regulation Number888.3040
Classification Product Code
MBI  
Subsequent Product Code
MAI  
Date Received04/09/2020
Decision Date 06/04/2020
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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