FDA 510(k)

Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction Changeable Lumbar Cage System, KEYSTONE Cage System

Número K: K230872 · 2023-12-12

RequerenteShanghai Sanyou Medical Co, Ltd.

Data da decisão2023-12-12

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction Changeable Lumbar Cage System, KEYSTONE Cage System is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Sanyou Medical Co, Ltd.. It received FDA 510(k) clearance on 2023-12-12 under 510(k) number K230872. 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 Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction Changeable Lumbar Cage System, KEYSTONE Cage System?

Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction Changeable Lumbar Cage System, KEYSTONE Cage System is a medical device that received FDA 510(k) clearance on 2023-12-12. The listed applicant is Shanghai Sanyou Medical Co, Ltd.. The 510(k) number is K230872.

When did Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction Changeable Lumbar Cage System, KEYSTONE Cage System receive FDA 510(k) clearance?

Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction Changeable Lumbar Cage System, KEYSTONE Cage System received FDA 510(k) clearance on 2023-12-12, under 510(k) number K230872.

Who is the listed applicant for Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction Changeable Lumbar Cage System, KEYSTONE Cage System?

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

What is the FDA product code for Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction Changeable Lumbar Cage System, KEYSTONE Cage System?

The FDA product code for Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction Changeable Lumbar Cage System, KEYSTONE Cage System is MAX.

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Fonte oficial

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