FDA 510(k)

肩部軟組織固定釘

K 號：K242477 · 2025-05-12

決定日期2025-05-12

產品代碼MBI

諮詢委員會或

決定相當於

器材摘要

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.

常見問題

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.

其他以 Signature Orthopaedics Pty, Ltd. 為申請人之記錄

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相關器械（代碼：MBI）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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