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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 K081414
Device Name MODIFICATION TO CORAL SPINAL SYSTEM
Applicant
Theken Spine, LLC
1800 Triplett Blvd.
Akron,  OH  44306
Applicant Contact DALE DAVISON
Correspondent
Theken Spine, LLC
1800 Triplett Blvd.
Akron,  OH  44306
Correspondent Contact DALE DAVISON
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI  
Date Received05/20/2008
Decision Date 06/17/2008
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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