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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K040426
Device Name TRANS1 AXIAL FIXATION SYSTEM
Applicant
TRANS1, INC.
1800 SIR TYLER DRIVE
SUITE 101
WILMINGTON,  NC  28405
Applicant Contact CHERYL L JOHNS
Correspondent
TRANS1, INC.
1800 SIR TYLER DRIVE
SUITE 101
WILMINGTON,  NC  28405
Correspondent Contact CHERYL L JOHNS
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received02/19/2004
Decision Date 12/17/2004
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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