FDA.reportPublic FDA data

510(k) K230808

Device
PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System
Applicant
Kyocera Medical Technologies, Inc.
510(k) number
K230808
Product code
OVD
Decision
Substantially Equivalent (SESE)
Decision date
2023-04-21
Date received
2023-03-23
Regulation
888.3080
Classification name
Intervertebral Fusion Device With Integrated Fixation, Lumbar
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Scott Rucker
Address
1200 California St. Suite 210 Redlands CA US 92374 92374

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OVD#

510(k), Device, Applicant table
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K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.2026-02-25
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K251644ProAM ALIF SystemPro Surgical, Inc.2025-06-24
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K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC2025-06-12
K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC2025-04-30
K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC2025-04-22
K250603AxTiHA® Stand-Alone ALIF SystemInnovasis2025-03-24
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