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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
Applicant Contact RANDY LEWIS
Correspondent
LIFE SPINE, INC
2401 W. HASSELL RD SUITE 1535
HOFFMAN ESTATES,  IL  60169
Correspondent Contact RANDY LEWIS
Regulation Number888.3080
Classification Product Code
OVE  
Date Received04/16/2012
Decision Date 11/16/2012
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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