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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name thoracolumbosacral pedicle screw system
510(k) Number K081108
Device Name MONOPOLY PEDICLE SCREW SYSTEM
Applicant
SIGNUS MEDICAL LLC.
1331 H ST NW
SUITE 1200
WASHINGTON,  DC  20005
Applicant Contact RICHARD JANSEN
Correspondent
SIGNUS MEDICAL LLC.
1331 H ST NW
SUITE 1200
WASHINGTON,  DC  20005
Correspondent Contact RICHARD JANSEN
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   MNH   MNI  
Date Received04/18/2008
Decision Date 07/14/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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