K252610
- 510(k) number
- K252610
- Device name
- ZSFab Lumbar Interbody System
- Applicant
- Zsfab, Inc. MA · US
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2025-11-25
- Date received
- 2025-08-18
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K252610.pdf
Official FDA record: K252610
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.