FDA 510(k)

Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups

Número K: K182705 · 2019-02-14

Data da decisão2019-02-14

Código do produtoLZO

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups is the device name listed in this FDA 510(k) record. The listed applicant is B-One Ortho, Corp.. It received FDA 510(k) clearance on 2019-02-14 under 510(k) number K182705. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups?

Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups is a medical device that received FDA 510(k) clearance on 2019-02-14. The listed applicant is B-One Ortho, Corp.. The 510(k) number is K182705.

When did Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups receive FDA 510(k) clearance?

Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups received FDA 510(k) clearance on 2019-02-14, under 510(k) number K182705.

Who is the listed applicant for Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups?

The FDA 510(k) record lists B-One Ortho, Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups?

The FDA product code for Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups is LZO.

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Dispositivos Relacionados (Código: LZO)

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Fonte oficial

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