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510(k) K113123

OIC CANNULATED SCREW SYSTEM, OIC SLIDING HIP SCREW (SHS) SYSTEM by The Orthopaedic Implant Company — Product Code KTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2012
Date Received
October 21, 2011
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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  • K181184 — OIC Intramedullary Nail System (July 27, 2018)

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