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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 K201883
Device Name 6.5 mm Healix Advance SP Peek Anchor, 6.5 mm 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 Number888.3040
Classification Product Code
MBI  
Subsequent Product Code
MAI  
Date Received07/08/2020
Decision Date 08/07/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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