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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 K050965
Device Name TRANS1 AXIALIF SYSTEM
Applicant
Trans1 Incorporated
1800 Sir Tyler Dr.
Suite 101
Wilmington,  NC  28405
Applicant Contact ROBERT L SHERIDAN
Correspondent
Trans1 Incorporated
1800 Sir Tyler Dr.
Suite 101
Wilmington,  NC  28405
Correspondent Contact ROBERT L SHERIDAN
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received04/18/2005
Decision Date 06/14/2005
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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