FDA 510(k)

Acumed手部固定系統 - 板材；Acumed手部固定系統 - 螺釘

K 號：K251132 · 2025-07-14

決定日期2025-07-14

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws is the device name listed in this FDA 510(k) record. The listed applicant is Acumed, LLC. It received FDA 510(k) clearance on 2025-07-14 under 510(k) number K251132. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws?

The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws is a medical device that received FDA 510(k) clearance on 2025-07-14. The listed applicant is Acumed, LLC. The 510(k) number is K251132.

When did The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws receive FDA 510(k) clearance?

The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws received FDA 510(k) clearance on 2025-07-14, under 510(k) number K251132.

Who is the listed applicant for The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws?

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 The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws?

The FDA product code for The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws is HRS.

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 K251296Acumed 手腕固定系統 K243624Acu-Sinch Knotless Mini K233311Acumed Wrist Plating System K230744Acumed Acutrak 3 Headless Compression Screw System K221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional

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相關器械（代碼：HRS）

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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官方來源

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