K241073
- 510(k) number
- K241073
- Device name
- DZ-Tabone Intervertebral Body Fusion Device
- Applicant
- Shenzhen Dazhou Medical Technology Co., Ltd. CN
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2024-12-06
- Date received
- 2024-04-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K241073.pdf
Official FDA record: K241073
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.