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510(k) K183682

OIC External Fixation System by Orthopaedic Implant Company — Product Code KTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2019
Date Received
December 28, 2018
Clearance Type
Traditional
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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