FDA.reportPublic FDA data

510(k) K231199

Device
Solar Lumbar Interbody Fusion System
Applicant
Degen Medical
510(k) number
K231199
Product code
MAX
Decision
Substantially Equivalent (SESE)
Decision date
2023-06-16
Date received
2023-04-27
Regulation
888.3080
Classification name
Intervertebral Fusion Device With Bone Graft, Lumbar
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Craig Black
Address
1321-C N. Cashua Dr. Florence SC US 29501 29501

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MAX#

510(k), Device, Applicant table
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K253266Titanium Interbody SystemSpine Innovation, LLC2026-01-08
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K252610ZSFab Lumbar Interbody SystemZsfab, Inc.2025-11-25
K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.2025-10-28
K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.2025-10-24
K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage (PLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Transforaminal Lumbar Interbody Fusion Cage (TLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Direct Lateral Lumbar Interbody Fusion Cage (DLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Anterior Lumbar Interbody Fusion Cage (ALIF))Mobarn Medical Devices, LLC2025-09-18
K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.2025-09-04