K260506
- 510(k) number
- K260506
- Device name
- Ventana® P/T Lumbar Interbody System
- Applicant
- Spinal Elements, Inc. CA · US
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2026-05-15
- Date received
- 2026-02-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K260506.pdf
Official FDA record: K260506
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.