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510(k) K192754

Avenger Radial Head System by In2bones USA, LLC — Product Code KWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2020
Date Received
September 30, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Elbow, Hemi-, Radial, Polymer
Device Class
Class II
Regulation Number
888.3170
Review Panel
OR
Submission Type

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