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510(k) K221572

VyPlate Anterior Cervical Plate System by Vy Spine, LLC — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 2022
Date Received
June 1, 2022
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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