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510(k) K160363

OPTIMUS CMF SYSTEM by Osteonic Co., Ltd. — Product Code JEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 2016
Date Received
February 9, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Bone
Device Class
Class II
Regulation Number
872.4760
Review Panel
DE
Submission Type

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