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510(k) K150655

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 2015
Date Received
March 13, 2015
Clearance Type
Traditional
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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