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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 K102334
Device Name TRANS1 AXIALIF PLUS
Applicant
Trans1 Incorporated
301 Government Center Dr.
Wilmington,  NC  28412
Applicant Contact CHERYL WAGONER
Correspondent
Trans1 Incorporated
301 Government Center Dr.
Wilmington,  NC  28412
Correspondent Contact CHERYL WAGONER
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received08/17/2010
Decision Date 03/14/2011
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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