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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 K213530
Device Name Nextra CH Cannulated Hammertoe System
Applicant
Nextremity Solutions, Inc.
1195 Polk Dr.
Warsaw,  IN  46582
Applicant Contact Elise Fox
Correspondent
Nextremity Solutions, Inc.
1195 Polk Dr.
Warsaw,  IN  46582
Correspondent Contact Elise Fox
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
NDL  
Date Received11/05/2021
Decision Date 12/09/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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