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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Facet Screw Spinal Device
510(k) Number K073515
Device Name TRANS1 FACET SCREW
Applicant
Trans1 Incorporated
411 Landmark Dr.
Wilmington,  NC  28412
Applicant Contact WILLIAM JACKSON
Correspondent
Trans1 Incorporated
411 Landmark Dr.
Wilmington,  NC  28412
Correspondent Contact WILLIAM JACKSON
Classification Product Code
MRW  
Date Received12/14/2007
Decision Date 03/11/2008
Decision Substantially Equivalent (SESE)
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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