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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sacroiliac joint fixation
510(k) Number K141246
Device Name LIFE SPINE SACROILIAC JOINT FIXATION 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 Number888.3040
Classification Product Code
OUR  
Subsequent Product Code
HWC  
Date Received05/14/2014
Decision Date 02/22/2015
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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