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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 K231704
Device Name Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System
Applicant
Life Spine, Inc.
13951 S Quality Dr.
Huntley,  IL  60142
Applicant Contact Angela Batker
Correspondent
Life Spine, Inc.
13951 S Quality Dr.
Huntley,  IL  60142
Correspondent Contact Angela Batker
Regulation Number888.3080
Classification Product Code
OVE  
Date Received06/12/2023
Decision Date 10/19/2023
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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