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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, Cervical
510(k) Number K221162
Device Name UniVy OsteoVy Cervical IBF System
Applicant
Vy Spine, LLC
2236 Capital Circle NE, Suite 103-1
Tallahassee,  FL  32308
Applicant Contact Jordan Hendrickson
Correspondent
Vy Spine, LLC
2236 Capital Circle NE, Suite 103-1
Tallahassee,  FL  32308
Correspondent Contact Jordon Hendrickson
Regulation Number888.3080
Classification Product Code
ODP  
Date Received04/22/2022
Decision Date 11/04/2022
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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