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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 bone graft, lumbar
510(k) Number K170919
Device Name The TiBow Expandable 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
MAX  
Date Received03/29/2017
Decision Date 08/03/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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