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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 K253260
Device Name ORIO-3D Cage System
Applicant
SpineCraft
777 Oakmont Ln.
Westmont,  IL  60559
Applicant Contact Ami Akallal-Asaad
Correspondent
SpineCraft
777 Oakmont Ln.
Westmont,  IL  60559
Correspondent Contact Ami Akallal-Asaad
Regulation Number888.3080
Classification Product Code
ODP  
Subsequent Product Codes
MAX   OVD  
Date Received09/29/2025
Decision Date 04/16/2026
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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