FDA 510(k)

Pegasus-X Expandable PLIF System

Número K: K221687 · 2022-07-27

Data da decisão2022-07-27

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Pegasus-X Expandable PLIF System is the device name listed in this FDA 510(k) record. The listed applicant is GS Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-07-27 under 510(k) number K221687. 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 Pegasus-X Expandable PLIF System?

Pegasus-X Expandable PLIF System is a medical device that received FDA 510(k) clearance on 2022-07-27. The listed applicant is GS Medical Co., Ltd.. The 510(k) number is K221687.

When did Pegasus-X Expandable PLIF System receive FDA 510(k) clearance?

Pegasus-X Expandable PLIF System received FDA 510(k) clearance on 2022-07-27, under 510(k) number K221687.

Who is the listed applicant for Pegasus-X Expandable PLIF System?

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

What is the FDA product code for Pegasus-X Expandable PLIF System?

The FDA product code for Pegasus-X Expandable PLIF System is MAX.

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Fonte oficial

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