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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name plate, fixation, bone
510(k) Number K150368
Device Name Tarsa-Link Wedge Fixation System
Applicant
Life Spine
13951 S. Quality Drive
Huntley,  IL  60142
Applicant Contact Randy Lewis
Correspondent
Life Spine
13951 S. Quality Drive
Huntley,  IL  60142
Correspondent Contact Randy Lewis
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received02/12/2015
Decision Date 03/24/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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