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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, Lumbar
510(k) Number K180215
Device Name DYNA-LINK ELITE Stand-Alone Anterior Lumbar System
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 Randy Lewis
Regulation Number888.3080
Classification Product Code
OVD  
Subsequent Product Code
MAX  
Date Received01/25/2018
Decision Date 09/13/2018
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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