BMD Titanium Spinal Fusion System— 510(k) K253894

Name: FDA 510(k) clearance K253894
Creator: U.S. Food and Drug Administration
Published: 2026-05-28

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.. Device class: 2.

Summary

Global Biomedica s.r.o. filed the BMD Titanium Spinal Fusion System under MAX, lumbar intervertebral fusion devices with bone graft. The record doesn't expand "BMD".

Class II, 21 CFR 888.3080. Orthopedic is both the classification panel and the review panel, and the submission was a Traditional 510(k).

Global Biomedica filed from the Czech Republic (the city in the record has garbled characters). Review took 175 calendar days (December 4, 2025 to May 28, 2026).

Clearance details

Applicant: Global Biomedica s.r.o.
Product code: Product code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
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 ↗

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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.