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FDA 510(k)

Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless)

Número K: K231002 · 2023-06-07

RequerenteSuzhou Endophix Co., Ltd.
Data da decisão2023-06-07
Código do produtoMBI
Comité consultivoOR
DecisãoSubstantially Equivalent

Resumo do dispositivo

Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless) is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Endophix Co., Ltd.. It received FDA 510(k) clearance on 2023-06-07 under 510(k) number K231002. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless)?

Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless) is a medical device that received FDA 510(k) clearance on 2023-06-07. The listed applicant is Suzhou Endophix Co., Ltd.. The 510(k) number is K231002.

When did Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless) receive FDA 510(k) clearance?

Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless) received FDA 510(k) clearance on 2023-06-07, under 510(k) number K231002.

Who is the listed applicant for Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless)?

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

What is the FDA product code for Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless)?

The FDA product code for Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless) is MBI.

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Outros registros que listam Suzhou Endophix Co., Ltd. como candidato(a)

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Dispositivos Relacionados (Código: MBI)

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Fonte oficial

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