FDA.reportPublic FDA data

510(k) K243934

Device
Stable-L Lumbar Interbody System
Applicant
Nexus Spine, LLC
510(k) number
K243934
Product code
OVD
Decision
Substantially Equivalent (SESE)
Decision date
2025-04-30
Date received
2024-12-20
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
Jared Crocker
Address
2825 E. Cottonwood Pkwy. Suite 330 Salt Lake City UT US 84121 84121

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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