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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K254274
Device Name ARx® SAI Implant System
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 Number888.3070
Classification Product Code
NKB  
Date Received12/30/2025
Decision Date 04/16/2026
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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