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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name orthosis, spinal pedicle fixation
510(K) Number K080841
Device Name COSMIC SYSTEM
Applicant
ULRICH GMBH & CO. KG
754 spirit 40 park drive
st. louis,  MO  63005
Contact merle symes
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
MNH  
Date Received03/26/2008
Decision Date 07/23/2008
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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