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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 K240505
Device Name Eminent Spine SI Screw System
Applicant
Eminent Spine, LLC
2004 Ventura Dr.
Suite 100
Plano,  TX  75093
Applicant Contact Stephen Courtney
Correspondent
Jalex Medical
27865 Clemens Rd.
Suite 3
Westlake,  OH  44145
Correspondent Contact Chhavy Tep-Cullison
Regulation Number888.3040
Classification Product Code
OUR  
Date Received02/21/2024
Decision Date 06/04/2024
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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