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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 K192532
Device Name Arthrex SwiveLock Anchor
Applicant
Arthrex Inc.
1370 Creekside Boulevard
naples,  FL  34108 -1945
Applicant Contact ivette galmez
Correspondent
Arthrex Inc.
1370 Creekside Boulevard
naples,  FL  34108 -1945
Correspondent Contact ivette galmez
Regulation Number888.3030
Classification Product Code
MAI  
Subsequent Product Code
HWC  
Date Received09/16/2019
Decision Date 10/19/2019
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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