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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K202836
Device Name GX Navigation Instrument 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 Number882.4560
Classification Product Code
OLO  
Date Received09/25/2020
Decision Date 08/19/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
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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