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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
Predetermined Change
Control Plan Authorized		 No
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