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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 K232611
Device Name TruLift Micro Expandable Spacer System & TruLift Expandable Spacer System
Applicant
Life Spine, Inc.
13951 S. Quality Drive
Huntley,  IL  60142
Applicant Contact Angela Batker
Correspondent
Life Spine, Inc.
13951 S. Quality Drive
Huntley,  IL  60142
Correspondent Contact Angela Batker
Regulation Number888.3080
Classification Product Code
MAX  
Date Received08/28/2023
Decision Date 11/30/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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