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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 K050058
Device Name THEKEN REVEAL VBR SYSTEM
Applicant
THEKEN SURGICAL,LLC
283 E WATERLOO RD.
AKRON,  OH  44319
Applicant Contact RANDY THEKEN
Correspondent
THEKEN SURGICAL,LLC
283 E WATERLOO RD.
AKRON,  OH  44319
Correspondent Contact RANDY THEKEN
Regulation Number888.3060
Classification Product Code
MQP  
Date Received01/11/2005
Decision Date 05/17/2005
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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