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510(k) K211112

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 2021
Date Received
April 14, 2021
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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