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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 K131521
Device Name VELOX ANTERIOR CERVICAL PLATE SYSTEM
Applicant
Spinecraft, LLC
777 Oakmont Lane
Westmont,  IL  60559
Applicant Contact AMI AKALLAL-ASAAD
Correspondent
Spinecraft, LLC
777 Oakmont Lane
Westmont,  IL  60559
Correspondent Contact AMI AKALLAL-ASAAD
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received05/28/2013
Decision Date 12/24/2013
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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