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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name appliance, fixation, spinal interlaminal
510(k) Number K120998
Device Name SOLSTICE CROSS CONNECTOR
Original Applicant
LIFE SPINE
2401 w. hassell rd.
suite 1535
hoffman estates,  IL  60169
Original Contact randy lewis
Regulation Number888.3050
Classification Product Code
KWP  
Date Received04/02/2012
Decision Date 10/01/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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