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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Smooth
510(k) Number K160264
Device Name Additive Orthopaedics Hammertoe Correction System
Applicant
Additive Orthopaedics, LLC
83 Amelia Cir.
Little Silver,  NJ  07739
Applicant Contact Greg Kowalczyk
Correspondent
Additive Orthopaedics, LLC
83 Amelia Cir.
Little Silver,  NJ  07739
Correspondent Contact Greg Kowalczyk
Regulation Number888.3040
Classification Product Code
HTY  
Date Received02/02/2016
Decision Date 06/01/2016
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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