K233375
- 510(k) number
- K233375
- Device name
- Tranquil-L Interbody System
- Applicant
- Nexus Spine, LLC UT · US
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2024-03-20
- Date received
- 2023-10-02
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K233375.pdf
Official FDA record: K233375
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.