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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 bone graft, lumbar
510(k) Number K153400
Device Name ProLift Expandable System
Applicant
LIFE SPINE, INC.
13951 S QUALITY DRIVE
HUNTLEY,  IL  60142
Applicant Contact RANDY LEWIS
Correspondent
LIFE SPINE, INC.
13951 S QUALITY DRIVE
HUNTLEY,  IL  60142
Correspondent Contact RANDY LEWIS
Regulation Number888.3080
Classification Product Code
MAX  
Date Received11/24/2015
Decision Date 03/07/2016
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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