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510(k) K210157

SOLE Medial Column Fusion Plate by Orthofix Srl — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 2021
Date Received
January 21, 2021
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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