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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Posterior Metal/Polymer Spinal System, Fusion
510(k) Number K031511
Device Name DYNESYS SPINAL SYSTEM
Applicant
CENTERPULSE SPINE-TECH, INC.
7375 BUSH LAKE RD.
MINNEAPOLIS,  MN  55439 -2027
Applicant Contact ANGELA BYLAND
Correspondent
CENTERPULSE SPINE-TECH, INC.
7375 BUSH LAKE RD.
MINNEAPOLIS,  MN  55439 -3037
Correspondent Contact Angela Byland
Regulation Number888.3070
Classification Product Code
NQP  
Date Received05/14/2003
Decision Date 03/05/2004
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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