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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
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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