K232069
- 510(k) number
- K232069
- Device name
- Expandable Lumbar Fusion Cage (Type I,Type II)
- Applicant
- Shanghai Reach Medical Instrument Co, Ltd. CN
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2023-11-29
- Date received
- 2023-07-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K232069.pdf
Official FDA record: K232069
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.