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510(k) K213901

Cyclops™ Anterior Cervical Plate System by Degen Medical — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2022
Date Received
December 14, 2021
Clearance Type
Special
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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