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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 K201319
Device Name Medline UNITE Jones Fracture Screw System
Applicant
Medline Industires, Inc.
Three Lakes Drive
Northfield,  IL  60030
Applicant Contact Jennifer Mason
Correspondent
Medline Industires, Inc.
Three Lakes Drive
Northfield,  IL  60030
Correspondent Contact Jennifer Mason
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HTN  
Date Received05/18/2020
Decision Date 06/17/2020
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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