BMD Titanium Spinal Fusion System— 510(k) K253894

Substantially Equivalent

Global Biomedica s.r.o.

FDA 510(k) clearance K253894 for BMD Titanium Spinal Fusion System, Substantially Equivalent on 2026-05-28. Applicant: Global Biomedica s.r.o..

Clearance details

Applicant: Global Biomedica s.r.o.
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2025-12-04
Decision date: 2026-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ceský Teín, CZ

Download summary PDF View on FDA.gov ↗

Adverse events under product code MAX

product code MAX

Death: 13
Injury: 1,305
Malfunction: 2,885
Total: 4,203

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.