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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Integrated Fixation, Cervical
510(k) Number K102323
Device Name CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICE
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 Number888.3080
Classification Product Code
OVE  
Date Received08/17/2010
Decision Date 12/16/2010
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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