FDA 510(k)

Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head

K-Nummer: K252824 · 2026-03-12

AntragstellerSignature Orthopaedics Pty, Ltd.

Entscheidungsdatum2026-03-12

ProduktcodeJDI

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head is the device name listed in this FDA 510(k) record. The listed applicant is Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2026-03-12 under 510(k) number K252824. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head?

Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head is a medical device that received FDA 510(k) clearance on 2026-03-12. The listed applicant is Signature Orthopaedics Pty, Ltd.. The 510(k) number is K252824.

When did Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head receive FDA 510(k) clearance?

Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head received FDA 510(k) clearance on 2026-03-12, under 510(k) number K252824.

Who is the listed applicant for Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head?

The FDA 510(k) record lists Signature Orthopaedics Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head?

The FDA product code for Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head is JDI.

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