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510(k) K212872

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2021
Date Received
September 9, 2021
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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Other clearances for product code KWI

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