FDA 510(k)

Acu-Sinch Knotless Mini

K 號：K243624 · 2025-01-23

決定日期2025-01-23

產品代碼HTN

諮詢委員會或

決定相當於

器材摘要

Acu-Sinch Knotless Mini is the device name listed in this FDA 510(k) record. The listed applicant is Acumed, LLC. It received FDA 510(k) clearance on 2025-01-23 under 510(k) number K243624. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Acu-Sinch Knotless Mini?

Acu-Sinch Knotless Mini is a medical device that received FDA 510(k) clearance on 2025-01-23. The listed applicant is Acumed, LLC. The 510(k) number is K243624.

When did Acu-Sinch Knotless Mini receive FDA 510(k) clearance?

Acu-Sinch Knotless Mini received FDA 510(k) clearance on 2025-01-23, under 510(k) number K243624.

Who is the listed applicant for Acu-Sinch Knotless Mini?

The FDA 510(k) record lists Acumed, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Acu-Sinch Knotless Mini?

The FDA product code for Acu-Sinch Knotless Mini is HTN.

其他以 Acumed, LLC 為申請人之記錄

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。

K252356Acumed 手腕固定系統 - 2.4mm 螺釘 K251132Acumed手部固定系統 - 板材；Acumed手部固定系統 - 螺釘 K251296Acumed 手腕固定系統 K233311Acumed Wrist Plating System K230744Acumed Acutrak 3 Headless Compression Screw System K221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional

查看所有 9 項裝置 →

相關器械（代碼：HTN）

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。

K253115LARS ACJMovmedix S.A.S.K252081運動連結關節固定器Lincotek Medical K253727關節固定緊繩PROArthrex, Inc.K251643Synchfix EVTWright Medical Technology, Inc. (Stryker Corporation)K251134RipCordTriMed, Inc.K242091博洛按鈕系統Fusion Orthopedics

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。