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FDA 510(k)

Shoulder Soft Tissue Anchors

K-Number: K242477 · 2025-05-12

ApplicantSignature Orthopaedics Pty, Ltd.
Decision Date2025-05-12
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Shoulder Soft Tissue Anchors is a medical device manufactured by Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2025-05-12 under approval number K242477. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Signature Orthopaedics Pty, Ltd.. The 510(k) number is K242477.

When was Shoulder Soft Tissue Anchors approved by the FDA?

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

What company makes Shoulder Soft Tissue Anchors?

Shoulder Soft Tissue Anchors is manufactured by Signature Orthopaedics Pty, Ltd..

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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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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