K261049
- 510(k) number
- K261049
- Device name
- SCALA® TL
- Applicant
- Spineart SA CH
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2026-08-20
- Date received
- 2026-03-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K261049.pdf
Official FDA record: K261049
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.