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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name intervertebral fusion device with bone graft, lumbar
510(k) Number K230219
Device Name Eminent Spine 3D Lumbar Interbody Fusion Systems
Applicant
Eminent Spine, LLC
2004 Ventura Drive, Suite #100
Plano,  TX  75093
Applicant Contact Stephen Courtney
Correspondent
Jalex Medical
27865 Clemens Rd Suite 3
Westlake,  OH  44145
Correspondent Contact Jennifer Palinchik
Regulation Number888.3080
Classification Product Code
MAX  
Date Received01/26/2023
Decision Date 05/16/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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