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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 bone graft, lumbar
510(k) Number K082712
Device Name THEKEN SPINE VU EPOD AND VU LPOD 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 Number888.3080
Classification Product Code
MAX  
Subsequent Product Code
MQP  
Date Received09/16/2008
Decision Date 01/02/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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