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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K260697
Device Name VyPlate™ Anterior Cervical Plate System
Applicant
Vy Spine, LLC
545 W 500 S.
Suite 100
Bountiful,  UT  84010
Applicant Contact Hendrickson Jordan
Correspondent
Vy Spine, LLC
545 W 500 S.
Suite 100
Bountiful,  UT  84010
Correspondent Contact Bret Berry
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received03/04/2026
Decision Date 03/27/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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