K252113
- 510(k) number
- K252113
- Device name
- PRADO Lumbar Interbody Fusion System
- Applicant
- Bethesda Medical Devices OH · US
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2025-08-05
- Date received
- 2025-07-07
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K252113.pdf
Official FDA record: K252113
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.