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510(k) K190992

OrthoPediatrics PediFoot Deformity Corrections System by OrthoPediatrics Corp. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 2019
Date Received
April 15, 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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