K241468
- 510(k) number
- K241468
- Device name
- Vertiwedge® Intraosseous System
- Applicant
- Foundation Surgical Group, Inc. AZ · US
- Product code
- MQP — Spinal Vertebral Body Replacement Device
- Decision date
- 2024-11-07
- Date received
- 2024-05-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 3.2 MB · U.S. public domain
Also available from FDA: K241468.pdf
Official FDA record: K241468
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.