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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K180166
Device Name Life Spine Lumbar Fixation System (SENTRY)
Applicant
Life Spine, Inc.
13951 S Quality Dr.
Huntley,  IL  60142
Applicant Contact Randy Lewis
Correspondent
Life Spine, Inc.
13951 S Quality Dr.
Huntley,  IL  60142
Correspondent Contact Angela Batker
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received01/22/2018
Decision Date 06/22/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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