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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 K200840
Device Name DuoHex CH Cannulated Hammertoe System
Applicant
Nextremity Solutions, Inc.
210 North Buffalo Street
Warsaw,  IN  46580
Applicant Contact Elise Fox
Correspondent
Nextremity Solutions, Inc.
210 North Buffalo Street
Warsaw,  IN  46580
Correspondent Contact Elise Fox
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
NDL  
Date Received03/31/2020
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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