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510(k) K201259

ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System by Wrightmedicaltechnologyinc — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 2021
Date Received
May 11, 2020
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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