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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 K253266
Device Name Titanium Interbody System
Applicant
Spine Innovation, LLC
1330 Orange Ave., Suite 328
Coronado,  CA  92118
Applicant Contact Jude Paganelli
Correspondent
Spine Innovation, LLC
1330 Orange Ave., Suite 328
Coronado,  CA  92118
Correspondent Contact Jude Paganelli
Regulation Number888.3080
Classification Product Code
MAX  
Date Received09/29/2025
Decision Date 01/08/2026
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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