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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 K122031
Device Name NEXTRA TI HAMMERTOE CORRECTION SYSTEM
Original Applicant
NEXTREMITY SOLUTIONS, LLC
167 stone hill rd.
colts neck,  NJ  07722
Original Contact arthur a alfaro
Regulation Number888.3040
Classification Product Code
HWC  
Date Received07/11/2012
Decision Date 10/09/2012
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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