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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 K180257
Device Name InCore® Lapidus System
Applicant
Nextremity Solutions, Inc.
210 North Buffalo Street
Warsaw,  IN  46580
Applicant Contact Greg Denham
Correspondent
Nextremity Solutions, Inc.
210 North Buffalo Street
Warsaw,  IN  46580
Correspondent Contact Greg Denham
Regulation Number888.3040
Classification Product Code
HWC  
Date Received01/30/2018
Decision Date 04/25/2018
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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