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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 K193521
Device Name Steerable Plateau Ti
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
MAX  
Date Received12/19/2019
Decision Date 02/06/2020
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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