K260549
- 510(k) number
- K260549
- Device name
- ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System
- Applicant
- Zsfab, Inc. MA · US
- Product code
- ODP — Intervertebral Fusion Device With Bone Graft, Cervic
- Decision date
- 2026-04-24
- Date received
- 2026-02-18
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K260549.pdf
Official FDA record: K260549
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.