K253894
- 510(k) number
- K253894
- Device name
- BMD Titanium Spinal Fusion System
- Applicant
- Global Biomedica s.r.o. CZ
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2026-05-28
- Date received
- 2025-12-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K253894.pdf
Official FDA record: K253894
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.