K242589
- 510(k) number
- K242589
- Device name
- Scarlet® AL-T
- Applicant
- Spineart SA CH
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2024-10-23
- Date received
- 2024-08-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K242589.pdf
Official FDA record: K242589
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.