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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name thoracolumbosacral pedicle screw system
510(k) Number K120829
Device Name STAINLESS STEEL SPINAL SYSTEM
Applicant
THEKEN SPINE, LLC
1153 Medina Rd.
Medina,  OH  44256
Applicant Contact DALE DAVISON
Correspondent
THEKEN SPINE, LLC
1153 Medina Rd.
Medina,  OH  44256
Correspondent Contact DALE DAVISON
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI  
Date Received03/19/2012
Decision Date 05/30/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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