K243074
- 510(k) number
- K243074
- Device name
- Spectrum Spine Lumbar Cage System
- Applicant
- Spectrum Spine, Inc. GA · US
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2025-04-04
- Date received
- 2024-09-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K243074.pdf
Official FDA record: K243074
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.