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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 K250773
Device Name Luna® Ti Interbody Fusion System
Applicant
Spinal Elements, Inc.
3115 S. Melrose Suite 200
Carlsbad,  CA  92010
Applicant Contact Cheryl Allen
Correspondent
Spinal Elements, Inc.
3115 S. Melrose Suite 200
Carlsbad,  CA  92010
Correspondent Contact Cheryl Allen
Regulation Number888.3080
Classification Product Code
MAX  
Date Received03/14/2025
Decision Date 02/04/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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