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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, Cervical
510(k) Number K180642
Device Name Pro-Link® Ti Stand-Alone Cervical Spacer 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
OVE  
Date Received03/12/2018
Decision Date 05/10/2018
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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