K232348
- 510(k) number
- K232348
- Device name
- RIGEL 3DR Standalone Anterior Cervical Interbody Fusion System
- Applicant
- MiRus, LLC GA · US
- Product code
- OVE — Intervertebral Fusion Device With Integrated Fixatio
- Decision date
- 2023-10-27
- Date received
- 2023-08-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K232348.pdf
Official FDA record: K232348
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.