FDA.report

510(k) K253559

Device
Ventana™ A Anterior Lumbar Interbody System
Applicant
Spinal Elements, Inc.
510(k) number
K253559
Product code
OVD
Decision
Substantially Equivalent (SESE)
Decision date
2026-02-25
Date received
2025-11-17
Regulation
888.3080
Classification name
Intervertebral Fusion Device With Integrated Fixation, Lumbar
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Cheryl Allen
Address
3115 Melrose Dr. Suite 200 Carlsbad CA US 92010 92010

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC2025-04-22
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K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.2025-03-17
K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.2024-12-13
K243191Atlas Spine Lateral Expandable Interbody SystemAtlas Spine, Inc.2024-11-26
K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical2024-10-29