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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 K171228
Device Name Fiji Anchor
Applicant
SportWelding GmbH
Wagistrasse 6
Schlieren,  CH 8952
Applicant Contact Joerg Mayer
Correspondent
Hogan Lovells US LLP
1835 Market Street, 29th Floor
Philadelphia,  PA  19103
Correspondent Contact Janice M. Hogan
Regulation Number888.3030
Classification Product Code
MAI  
Subsequent Product Codes
GAT   HTY  
Date Received04/26/2017
Decision Date 01/19/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Clinical Trials NCT02042846
Reviewed by Third Party No
Combination Product No
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