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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 K231836
Device Name ClariVy™ 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 Jordan Hendrickson
Regulation Number888.3080
Classification Product Code
ODP  
Subsequent Product Code
OVE  
Date Received06/22/2023
Decision Date 10/30/2023
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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