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510(k) K220809

Drive Rail System by OrthoPediatrics Corp. — Product Code KTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2022
Date Received
March 21, 2022
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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