FDA 510(k)

BMD Titanium Spinal Fusion System

Número K: K253894 · 2026-05-28

Data da decisão2026-05-28

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

BMD Titanium Spinal Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Global Biomedica s.r.o.. It received FDA 510(k) clearance on 2026-05-28 under 510(k) number K253894. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BMD Titanium Spinal Fusion System?

BMD Titanium Spinal Fusion System is a medical device that received FDA 510(k) clearance on 2026-05-28. The listed applicant is Global Biomedica s.r.o.. The 510(k) number is K253894.

When did BMD Titanium Spinal Fusion System receive FDA 510(k) clearance?

BMD Titanium Spinal Fusion System received FDA 510(k) clearance on 2026-05-28, under 510(k) number K253894.

Who is the listed applicant for BMD Titanium Spinal Fusion System?

The FDA 510(k) record lists Global Biomedica s.r.o. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BMD Titanium Spinal Fusion System?

The FDA product code for BMD Titanium Spinal Fusion System is MAX.

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