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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
Applicant
NEXTREMITY SOLUTIONS, LLC
167 stone hill rd.
colts neck,  NJ  07722
Contact arthur a alfaro
Regulation Number888.3040
Classification Product Code
HWC  
Date Received07/11/2012
Decision Date 10/09/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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