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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 K200226
Device Name RetroFix
Applicant
Retrofix Screws, LLC
1035 Lincolnton Road
salisbury,  NC  28144
Applicant Contact keith a barritt
Correspondent
Fish & Richardson P.C.
1000 Maine Avenue, S.W. Suite 1000
washington,  DC  20024
Correspondent Contact keith a barritt
Regulation Number888.3040
Classification Product Code
HWC  
Date Received01/30/2020
Decision Date 06/26/2020
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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