K232530
- 510(k) number
- K232530
- Device name
- Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System
- Applicant
- Nexus Spine, LLC UT · US
- Product code
- OVD — Intervertebral Fusion Device With Integrated Fixatio
- Decision date
- 2023-09-18
- Date received
- 2023-08-21
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K232530.pdf
Official FDA record: K232530
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.