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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 K260506
Device Name Ventana® P/T Lumbar Interbody System
Applicant
Spinal Elements, Inc.
3115 Melrose Dr. Suite 200
Carlsbad,  CA  92010
Applicant Contact Sartaj Kaur-Hurrle
Correspondent
Spinal Elements, Inc.
3115 Melrose Dr. Suite 200
Carlsbad,  CA  92010
Correspondent Contact Sartaj Kaur-Hurrle
Regulation Number888.3080
Classification Product Code
MAX  
Date Received02/17/2026
Decision Date 05/15/2026
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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