K261810
- 510(k) number
- K261810
- Device name
- Vertiwedge® Intraosseous System
- Applicant
- Foundation Surgical Group AZ · US
- Product code
- MQP — Spinal Vertebral Body Replacement Device
- Decision date
- 2026-07-31
- Date received
- 2026-06-01
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K261810.pdf
Official FDA record: K261810
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.