K254017
- 510(k) number
- K254017
- Device name
- SWINGO-3D Lumbar Cage System
- Applicant
- Implanet FR
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2026-02-26
- Date received
- 2025-12-15
- 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: K254017.pdf
Official FDA record: K254017
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.