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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, Cervical
510(k) Number K111675
Device Name VU C*POD INTERVERTEBRAL BODY FUSION DEVICE
Applicant
Theken Spine, LLC
1153 Medina Rd.
Medina,  OH  44256 -0000
Applicant Contact DALE DAVISON
Correspondent
Theken Spine, LLC
1153 Medina Rd.
Medina,  OH  44256 -0000
Correspondent Contact DALE DAVISON
Regulation Number888.3080
Classification Product Code
ODP  
Date Received06/15/2011
Decision Date 08/02/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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