FDA 510(k)

Osteo-site Vertebral Balloon

Número K: K200763 · 2020-08-12

Data da decisão2020-08-12

Código do produtoHRX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Osteo-site Vertebral Balloon is the device name listed in this FDA 510(k) record. The listed applicant is Izi Medical. It received FDA 510(k) clearance on 2020-08-12 under 510(k) number K200763. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Osteo-site Vertebral Balloon?

Osteo-site Vertebral Balloon is a medical device that received FDA 510(k) clearance on 2020-08-12. The listed applicant is Izi Medical. The 510(k) number is K200763.

When did Osteo-site Vertebral Balloon receive FDA 510(k) clearance?

Osteo-site Vertebral Balloon received FDA 510(k) clearance on 2020-08-12, under 510(k) number K200763.

Who is the listed applicant for Osteo-site Vertebral Balloon?

The FDA 510(k) record lists Izi Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Osteo-site Vertebral Balloon?

The FDA product code for Osteo-site Vertebral Balloon is HRX.

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