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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name screw, fixation, bone
510(k) Number K190921
Device Name Arthrex Low Profile Screws
Applicant
Arthrex Inc.
1370 Creekside Boulevard
naples,  FL  34108 -1945
Applicant Contact heli f. chambi infantas
Correspondent
Arthrex Inc.
1370 Creekside Boulevard
naples,  FL  34108 -1945
Correspondent Contact heli f. chambi infantas
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HRS  
Date Received04/09/2019
Decision Date 10/30/2019
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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