Avenger Radial Head System

Prosthesis, Elbow, Hemi-, Radial, Polymer

In2Bones USA, LLC

The following data is part of a premarket notification filed by In2bones Usa, Llc with the FDA for Avenger Radial Head System.

Pre-market Notification Details

Device IDK212872
510k NumberK212872
Device Name:Avenger Radial Head System
ClassificationProsthesis, Elbow, Hemi-, Radial, Polymer
Applicant In2Bones USA, LLC 6000 Poplar Ave, Suite 115 Memphis,  TN  38119
ContactChristine Scifert
CorrespondentChristine Scifert
In2Bones USA, LLC 6000 Poplar Ave, Suite 115 Memphis,  TN  38119
Product CodeKWI  
CFR Regulation Number888.3170 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-09
Decision Date2021-12-17

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