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510(k) K140357

OIC VARIABLE ANGLE SMALL FRAGMENT LOCKING PLATE SYSTEM by Orthopaedic Implant Company — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 2014
Date Received
February 12, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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