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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 K070385
Device Name TI-TAMED SPINAL SYSTEM
Applicant
Ti-Tamed (Pty), Ltd.
54 Auckland St.
Paarden Eiland
Cape Town, Western Cape,  ZA 7405
Applicant Contact SANDRA MORTIMER
Correspondent
Ti-Tamed (Pty), Ltd.
54 Auckland St.
Paarden Eiland
Cape Town, Western Cape,  ZA 7405
Correspondent Contact SANDRA MORTIMER
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWQ   MNH   MNI  
Date Received02/09/2007
Decision Date 07/31/2009
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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