K231486
- 510(k) number
- K231486
- Device name
- Stable-L Standalone Lumbar Interbody System
- Applicant
- Nexus Spine, LLC UT · US
- Product code
- OVD — Intervertebral Fusion Device With Integrated Fixatio
- Decision date
- 2023-10-12
- Date received
- 2023-05-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K231486.pdf
Official FDA record: K231486
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.