FDA 510(k)

OsteoMed ExtremiFix Mini 與小型系統托盤

K 號：K202105 · 2020-10-29

決定日期2020-10-29

產品代碼KCT

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

OsteoMed ExtremiFix Mini & Small System Tray is the device name listed in this FDA 510(k) record. The listed applicant is Osteomed, LLC. It received FDA 510(k) clearance on 2020-10-29 under 510(k) number K202105. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OsteoMed ExtremiFix Mini & Small System Tray?

OsteoMed ExtremiFix Mini & Small System Tray is a medical device that received FDA 510(k) clearance on 2020-10-29. The listed applicant is Osteomed, LLC. The 510(k) number is K202105.

When did OsteoMed ExtremiFix Mini & Small System Tray receive FDA 510(k) clearance?

OsteoMed ExtremiFix Mini & Small System Tray received FDA 510(k) clearance on 2020-10-29, under 510(k) number K202105.

Who is the listed applicant for OsteoMed ExtremiFix Mini & Small System Tray?

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

What is the FDA product code for OsteoMed ExtremiFix Mini & Small System Tray?

The FDA product code for OsteoMed ExtremiFix Mini & Small System Tray is KCT.

其他以 Osteomed, 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。

K212570骨質計劃系統 K202680OsteoMed ExtremiFix Mini 與小型中空螺釘系統 K173391骨醫快速修復混合MMF消毒托盤 K163303OsteoMed ExtremiFix 中大型釘針系統

相關器械（代碼：KCT）

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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