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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 K210061
Device Name ProLift Lateral HELO Fixated
Applicant
Life Spine, Inc.
139541 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  
Subsequent Product Code
OVD  
Date Received01/11/2021
Decision Date 04/30/2021
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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