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FDA 510(k) Application Details - K051856
Device Classification Name
System, Facet Screw Spinal Device
More FDA Info for this Device
510(K) Number
K051856
Device Name
System, Facet Screw Spinal Device
Applicant
TRANS1 INCORPORATED
1800 SIR TYLER DRIVE
SUITE 101
WILMINGTON, NC 28405 US
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Contact
ROBERT L SHERIDAN
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Regulation Number
000.0000
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Classification Product Code
MRW
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More FDA Info for this Product Code
Date Received
07/08/2005
Decision Date
09/26/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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