K253011
- 510(k) number
- K253011
- Device name
- Catalyft PL Expandable Interbody System
- Applicant
- Medtronic Sofamor Danek USA, Inc. TN · US
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2026-07-17
- Date received
- 2025-09-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K253011.pdf
Official FDA record: K253011
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.