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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K180239
Device Name Additive Orthopaedics Patient Specific 3D Printed Bone Segments
Applicant
Additive Orthopaedics, LLC
83 Amelia Circle
Little Silver,  NJ  07739
Applicant Contact Gregory Kowalczyk
Correspondent
Additive Orthopaedics, LLC
83 Amelia Circle
Little Silver,  NJ  07739
Correspondent Contact Gregory Kowalczyk
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received01/29/2018
Decision Date 05/16/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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