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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Lumbar
510(k) Number K241783
Device Name FortiVy™ OsteoVy™ Lumbar IBF
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 Number888.3080
Classification Product Code
MAX  
Date Received06/20/2024
Decision Date 03/18/2025
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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