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510(k) K212405

EMERGE™ Anterior Cervical Plate System by Evolution Spine — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2021
Date Received
August 2, 2021
Clearance Type
Abbreviated
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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