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510(k) K201587

icotec Anterior Cervical Plate System by Icotec AG — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 2020
Date Received
June 11, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Intervertebral Body
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

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