FDA 510(k)

OsteoMed ExtremiFix 中大型釘針系統

K 號：K163303 · 2017-04-04

決定日期2017-04-04

產品代碼HWC

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器材摘要

OsteoMed ExtremiFix Mid and Large Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Osteomed, LLC. It received FDA 510(k) clearance on 2017-04-04 under 510(k) number K163303. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the OsteoMed ExtremiFix Mid and Large Screw System?

OsteoMed ExtremiFix Mid and Large Screw System is a medical device that received FDA 510(k) clearance on 2017-04-04. The listed applicant is Osteomed, LLC. The 510(k) number is K163303.

When did OsteoMed ExtremiFix Mid and Large Screw System receive FDA 510(k) clearance?

OsteoMed ExtremiFix Mid and Large Screw System received FDA 510(k) clearance on 2017-04-04, under 510(k) number K163303.

Who is the listed applicant for OsteoMed ExtremiFix Mid and Large Screw System?

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 Mid and Large Screw System?

The FDA product code for OsteoMed ExtremiFix Mid and Large Screw System is HWC. This falls under the Cardiovascular category.

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 K202105OsteoMed ExtremiFix Mini 與小型系統托盤 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

相關器械（代碼：HWC）

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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