K232481
- 510(k) number
- K232481
- Device name
- RIGEL 3DR Anterior Cervical Corpectomy System
- Applicant
- MiRus, LLC GA · US
- Product code
- PLR — Spinal Vertebral Body Replacement Device - Cervical
- Decision date
- 2023-10-13
- Date received
- 2023-08-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K232481.pdf
Official FDA record: K232481
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.