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510(k) K181184

OIC Intramedullary Nail System by The Orthopaedic Implant Company — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 2018
Date Received
May 3, 2018
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rod, Fixation, Intramedullary And Accessories
Device Class
Class II
Regulation Number
888.3020
Review Panel
OR
Submission Type

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