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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 Interlaminal
510(k) Number K080790
Device Name MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC 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 Number888.3050
Classification Product Code
KWP  
Subsequent Product Code
MNI  
Date Received03/20/2008
Decision Date 04/29/2008
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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