FDA 510(k)

Freefix 腕骨固定系統

K 號：K242055 · 2024-08-01

決定日期2024-08-01

產品代碼HRS

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決定相當於

器材摘要

Freefix Forearm Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Skeletal Dynamics, Inc.. It received FDA 510(k) clearance on 2024-08-01 under 510(k) number K242055. 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 Freefix Forearm Plating System?

Freefix Forearm Plating System is a medical device that received FDA 510(k) clearance on 2024-08-01. The listed applicant is Skeletal Dynamics, Inc.. The 510(k) number is K242055.

When did Freefix Forearm Plating System receive FDA 510(k) clearance?

Freefix Forearm Plating System received FDA 510(k) clearance on 2024-08-01, under 510(k) number K242055.

Who is the listed applicant for Freefix Forearm Plating System?

FDA 510(k) 記錄將 Skeletal Dynamics, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Freefix Forearm Plating System?

The FDA product code for Freefix Forearm Plating System is HRS.

其他以 Skeletal Dynamics, Inc. 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。

K261770縫針按鈕修復系統 K254288鎖骨固定系統 K252949Geminus Volar 腕骨遠端板片系統 K242436近端肱骨固定系統 K243381全腕關節置換系統 (TWA)K241815Protean 適體片段培植系統

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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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