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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name thoracolumbosacral pedicle screw system
510(k) Number K143683
Device Name APEX-DL Spine 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 Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   MNH   MNI   OSH  
Date Received12/24/2014
Decision Date 05/22/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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