K233359
- 510(k) number
- K233359
- Device name
- DOMINION Expandable Corpectomy System
- Applicant
- Astura Medical TX · US
- Product code
- MQP — Spinal Vertebral Body Replacement Device
- Decision date
- 2024-03-08
- Date received
- 2023-09-29
- 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: K233359.pdf
Official FDA record: K233359
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.