K230872
- 510(k) number
- K230872
- Device name
- Halis Lumbar Cage System, Lydia Anterior Lumbar Fusion System, Dica Direction Changeable Lumbar Cage System, KEYSTONE Cage System
- Applicant
- Shanghai Sanyou Medical Co, Ltd. CN
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2023-12-12
- Date received
- 2023-03-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K230872.pdf
Official FDA record: K230872
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.