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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spondylolisthesis Spinal Fixation
510(k) Number K102488
Device Name APEX SPINE SYSTEM W/ COCR RODS
Applicant
Spinecraft, LLC
2215 Enterprise Dr.
Suite 1504
Westchester,  IL  60154
Applicant Contact AMI AKALLAL-ASAAD
Correspondent
Spinecraft, LLC
2215 Enterprise Dr.
Suite 1504
Westchester,  IL  60154
Correspondent Contact AMI AKALLAL-ASAAD
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Codes
KWP   KWQ   MNI  
Date Received08/31/2010
Decision Date 12/10/2010
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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