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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name screw, fixation, bone
510(k) Number K150126
Device Name Life Spine Cannulated Screws
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 Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HRS  
Date Received01/20/2015
Decision Date 05/11/2015
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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