FDA 510(k)

FORZA XP Expandable Spacer System

Número K: K213951 · 2022-01-05

Data da decisão2022-01-05

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

FORZA XP Expandable Spacer System is the device name listed in this FDA 510(k) record. The listed applicant is Orthofix US, LLC. It received FDA 510(k) clearance on 2022-01-05 under 510(k) number K213951. 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 FORZA XP Expandable Spacer System?

FORZA XP Expandable Spacer System is a medical device that received FDA 510(k) clearance on 2022-01-05. The listed applicant is Orthofix US, LLC. The 510(k) number is K213951.

When did FORZA XP Expandable Spacer System receive FDA 510(k) clearance?

FORZA XP Expandable Spacer System received FDA 510(k) clearance on 2022-01-05, under 510(k) number K213951.

Who is the listed applicant for FORZA XP Expandable Spacer System?

The FDA 510(k) record lists Orthofix US, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FORZA XP Expandable Spacer System?

The FDA product code for FORZA XP Expandable Spacer System is MAX.

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Fonte oficial

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