K230961
- 510(k) number
- K230961
- Device name
- Zeus Spinal System
- Applicant
- Shanghai Sanyou Medical Co, Ltd. CN
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2023-10-10
- Date received
- 2023-04-05
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K230961.pdf
Official FDA record: K230961
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.