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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 K252711
Device Name Advantage-C™ Ti3D Cervical Interbody Fusion Device
Applicant
Intelivation Technologies
500 S Gravers Rd.
Suite 200
Plymouth Meeting,  PA  19462
Applicant Contact Thara Moussaoui
Correspondent
Intelivation Technologies
500 S Gravers Rd.
Suite 200
Plymouth Meeting,  PA  19462
Correspondent Contact Amit Sinha
Regulation Number888.3080
Classification Product Code
ODP  
Date Received08/27/2025
Decision Date 01/08/2026
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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