FDA.reportPublic FDA data

510(k) K241077

Device
DeGen Medical Patient Specific Implant (PSI) System
Applicant
Degen Medical
510(k) number
K241077
Product code
OVD
Decision
Substantially Equivalent (SESE)
Decision date
2024-10-29
Date received
2024-04-19
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
No

Applicant Contact#

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

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K251644ProAM ALIF SystemPro Surgical, Inc.2025-06-24
K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.2025-06-18
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