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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sacroiliac Joint Fixation
510(k) Number K241464
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 Number888.3040
Classification Product Code
OUR  
Subsequent Product Code
NKB  
Date Received05/23/2024
Decision Date 07/29/2024
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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