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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 K120891
Device Name TANGORS MULTIFUNCTIONAL POSTERIOR SYSTEM
Applicant
ULRICH GMBH & CO. KG
612 trade center blvd
chesterfield,  MO  63005
Applicant Contact hans stover
Correspondent
ULRICH GMBH & CO. KG
612 trade center blvd
chesterfield,  MO  63005
Correspondent Contact hans stover
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received03/23/2012
Decision Date 10/01/2012
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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