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510(k) K191641

AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius Plates, AFFINITY – Variable Angle Distal Radius Screws by Industrias Medicas Sampedro S.A.S — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 2019
Date Received
June 19, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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