K240416
- 510(k) number
- K240416
- Device name
- Tranquil-C Interbody System
- Applicant
- Nexus Spine, LLC UT · US
- Product code
- ODP — Intervertebral Fusion Device With Bone Graft, Cervic
- Decision date
- 2024-03-12
- Date received
- 2024-02-12
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K240416.pdf
Official FDA record: K240416
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.