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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 K260571
Device Name SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments
Applicant
Life Spine, Inc.
13951 Quality Dr.
Huntley,  IL  60142
Applicant Contact Angela Batker
Correspondent
Life Spine, Inc.
13951 Quality Dr.
Huntley,  IL  60142
Correspondent Contact Angela Batker
Regulation Number882.4560
Classification Product Code
OLO  
Date Received02/19/2026
Decision Date 06/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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