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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 K052385
Device Name TANGORS POLYAXIAL SYSTEM
Applicant
Ulrich GmbH & Co. KG
Buchbrunnenweg 12
Ulm,  DE D-89081
Applicant Contact CHRISTOPH ULRICH
Correspondent
Ulrich GmbH & Co. KG
Buchbrunnenweg 12
Ulm,  DE D-89081
Correspondent Contact CHRISTOPH ULRICH
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received08/30/2005
Decision Date 12/27/2005
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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