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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spine, Plate, Laminoplasty, Metal
510(k) Number K242784
Device Name Vy Spine™ VyLam™ Laminoplasty System
Applicant
Vy Spine, LLC
545 W 500 S.
Suite 100
Bountiful,  UT  84011
Applicant Contact Jordan Hendrickson
Correspondent
Vy Spine, LLC
545 W 500 S.
Suite 100
Bountiful,  UT  84011
Correspondent Contact Jordan Hendrickson
Regulation Number888.3050
Classification Product Code
NQW  
Date Received09/16/2024
Decision Date 10/16/2024
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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