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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 K192578
Device Name InCore TMT System
Applicant
Nextremity Solutions, Inc.
210 N. Buffalo St.
Warsaw,  IN  46580
Applicant Contact Elise Fox
Correspondent
Nextremity Solutions, Inc.
210 N. Buffalo St.
Warsaw,  IN  46580
Correspondent Contact Elise Fox
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
LXH  
Date Received09/19/2019
Decision Date 12/31/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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