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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 Intervertebral Body
510(k) Number K080690
Device Name MANTA RAY ANTERIOR CERVICAL PLATE 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 Number888.3060
Classification Product Code
KWQ  
Date Received03/11/2008
Decision Date 04/25/2008
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
Recalls CDRH Recalls
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