K241775
- 510(k) number
- K241775
- Device name
- XeliteMed VertehighFix High Viscosity Spinal Bone Cement
- Applicant
- Xelite Biomed , Ltd. TW
- Product code
- NDN — Cement, Bone, Vertebroplasty
- Decision date
- 2024-09-18
- Date received
- 2024-06-20
- 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: K241775.pdf
Official FDA record: K241775
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.