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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spinal Vertebral Body Replacement Device
510(k) Number K253158
Device Name VyBrate™ VBR System
Applicant
Vy Spine, LLC
545 W 500 S.
Suite 100
Bountiful,  UT  84010
Applicant Contact Jordan Hendrickson
Correspondent
Vy Spine, LLC
545 W 500 S.
Suite 100
Bountiful,  UT  84010
Correspondent Contact Jordan Hendrickson
Regulation Number888.3060
Classification Product Code
MQP  
Subsequent Product Code
PLR  
Date Received09/26/2025
Decision Date 01/07/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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