FDA 510(k)

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

K-Nummer: K230872 · 2023-12-12

AntragstellerShanghai Sanyou Medical Co, Ltd.

Entscheidungsdatum2023-12-12

ProduktcodeMAX

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

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.

Häufig gestellte Fragen

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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Offizielle Quelle

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