FDA 510(k)

Shoulder Soft Tissue Anchors

Número K: K242477 · 2025-05-12

RequerenteSignature Orthopaedics Pty, Ltd.

Data da decisão2025-05-12

Código do produtoMBI

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Shoulder Soft Tissue Anchors 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 2025-05-12 under 510(k) number K242477. 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 Shoulder Soft Tissue Anchors?

Shoulder Soft Tissue Anchors is a medical device that received FDA 510(k) clearance on 2025-05-12. The listed applicant is Signature Orthopaedics Pty, Ltd.. The 510(k) number is K242477.

When did Shoulder Soft Tissue Anchors receive FDA 510(k) clearance?

Shoulder Soft Tissue Anchors received FDA 510(k) clearance on 2025-05-12, under 510(k) number K242477.

Who is the listed applicant for Shoulder Soft Tissue Anchors?

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 Shoulder Soft Tissue Anchors?

The FDA product code for Shoulder Soft Tissue Anchors is MBI.

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Fonte oficial

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