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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 K070638
Device Name THEKEN ATOLL CERVICO-THORACIC SYSTEM
Applicant
Theken Spine, LLC
283 E. Waterloo Rd.
Akron,  OH  44319
Applicant Contact DALE DAVISON
Correspondent
Theken Spine, LLC
283 E. Waterloo Rd.
Akron,  OH  44319
Correspondent Contact DALE DAVISON
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Code
MNI  
Date Received03/07/2007
Decision Date 05/30/2007
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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