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510(k) K152098

ODALYS Pedicle Screw System by Kisco International — Product Code MNI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2015
Date Received
July 28, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Spinal Pedicle Fixation
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

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