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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 Integrated Fixation, Lumbar
510(k) Number K253559
Device Name Ventana™ A Anterior Lumbar Interbody System
Applicant
Spinal Elements, Inc.
3115 Melrose Dr. Suite 200
Carlsbad,  CA  92010
Applicant Contact Cheryl Allen
Correspondent
Spinal Elements, Inc.
3115 Melrose Dr. Suite 200
Carlsbad,  CA  92010
Correspondent Contact Cheryl Allen
Regulation Number888.3080
Classification Product Code
OVD  
Date Received11/17/2025
Decision Date 02/25/2026
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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