K243188
- 510(k) number
- K243188
- Device name
- CYLOX® ST
- Applicant
- Signus Medizintechnik GmbH DE
- Product code
- OVE — Intervertebral Fusion Device With Integrated Fixatio
- Decision date
- 2025-02-11
- Date received
- 2024-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K243188.pdf
Official FDA record: K243188
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.