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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spinal Pedicle Fixation
510(k) Number K083073
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 Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
KWP  
Date Received10/15/2008
Decision Date 03/13/2009
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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