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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 K242069
Device Name Eminent Spine Scoliosis Deformity Pedicle Screw System
Applicant
Eminent Spine
2004 Ventura Dr.
Suite 100
Plano,  TX  75093
Applicant Contact Stephen Courtney
Correspondent
Eminent Spine
2004 Ventura Dr.
Suite 100
Plano,  TX  75093
Correspondent Contact Stephen Courtney
Regulation Number888.3070
Classification Product Code
NKB  
Date Received07/15/2024
Decision Date 09/03/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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