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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spinal Vertebral Body Replacement Device
510(k) Number K071031
Device Name VU E*POD VERTEBRAL BODY REPLACEMENT
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 Number888.3060
Classification Product Code
MQP  
Date Received04/11/2007
Decision Date 07/30/2007
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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