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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name intervertebral fusion device with integrated fixation, cervical
510(K) Number K121151
Device Name PRO-LINK CERVICAL SPACER SYSTEM
Applicant
LIFE SPINE, INC
2401 w. hassell rd suite 1535
hoffman estates,  IL  60169
Contact randy lewis
Regulation Number888.3080
Classification Product Code
OVE  
Date Received04/16/2012
Decision Date 11/16/2012
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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