K243739
- 510(k) number
- K243739
- Device name
- AxCess® Expandable Interbody System
- Applicant
- Elliquence, LLC NY · US
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2025-01-24
- Date received
- 2024-12-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K243739.pdf
Official FDA record: K243739
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.