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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K260015
Device Name ANTERIS Thoracolumbar Plate 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 Number888.3060
Classification Product Code
KWQ  
Date Received01/05/2026
Decision Date 03/04/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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