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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 K051856
Device Name TRANS1 FACET SCREWS
Applicant
TRANS1 INCORPORATED
1800 SIR TYLER DRIVE
SUITE 101
WILMINGTON,  NC  28405
Applicant Contact ROBERT L SHERIDAN
Correspondent
TRANS1 INCORPORATED
1800 SIR TYLER DRIVE
SUITE 101
WILMINGTON,  NC  28405
Correspondent Contact ROBERT L SHERIDAN
Classification Product Code
MRW  
Date Received07/08/2005
Decision Date 09/26/2005
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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