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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, biodegradable, soft tissue
510(k) Number K191242
Device Name HEALIX ADVANCE SP BIOCOMPOSITE Anchor
Applicant
Medos International SARL
Chemin-Blanc 38, Case Postale
Le Locle,  CH CH 2400
Applicant Contact Elizabeth Messana
Correspondent
DePuy Synthes Mitek, a Johnson and Johnson Company
325 Paramount Drive
Raynham,  MA  02767
Correspondent Contact Elizabeth Messana
Regulation Number888.3030
Classification Product Code
MAI  
Date Received05/09/2019
Decision Date 08/22/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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