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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 K103228
Device Name PARAMOUNT R IBF 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
MAX  
Date Received11/02/2010
Decision Date 01/05/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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