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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Elbow, Hemi-, Radial, Polymer
510(k) Number K192754
Device Name Avenger Radial Head System
Applicant
In2bones USA, LLC
6000 Poplar Ave. Suite 115
Memphis,  TN  38119
Applicant Contact Christine Scifert
Correspondent
In2bones USA, LLC
6000 Poplar Ave. Suite 115
Memphis,  TN  38119
Correspondent Contact Christine Scifert
Regulation Number888.3170
Classification Product Code
KWI  
Date Received09/30/2019
Decision Date 01/07/2020
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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