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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 K253583
Device Name LUX Expandable Lumbar Interbody System
Applicant
Xenix Medical
149 W. Michigan St.
Orlando,  CA  32806
Applicant Contact Teresa Cherry
Correspondent
Xenix Medical
149 W. Michigan St.
Orlando,  CA  32806
Correspondent Contact Teresa Cherry
Regulation Number888.3080
Classification Product Code
MAX  
Date Received11/17/2025
Decision Date 02/23/2026
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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