FDA 510(k)

Fixxsure 前腰椎板及螺釘系統

K 號：K211932 · 2021-07-27

決定日期2021-07-27

產品代碼KWQ

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決定相當於

器材摘要

Fixxsure Anterior Lumbar Plate and Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Oak Tree Engineering, LLC. It received FDA 510(k) clearance on 2021-07-27 under 510(k) number K211932. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Fixxsure Anterior Lumbar Plate and Screw System?

Fixxsure Anterior Lumbar Plate and Screw System is a medical device that received FDA 510(k) clearance on 2021-07-27. The listed applicant is Oak Tree Engineering, LLC. The 510(k) number is K211932.

When did Fixxsure Anterior Lumbar Plate and Screw System receive FDA 510(k) clearance?

Fixxsure Anterior Lumbar Plate and Screw System received FDA 510(k) clearance on 2021-07-27, under 510(k) number K211932.

Who is the listed applicant for Fixxsure Anterior Lumbar Plate and Screw System?

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

What is the FDA product code for Fixxsure Anterior Lumbar Plate and Screw System?

The FDA product code for Fixxsure Anterior Lumbar Plate and Screw System is KWQ.

其他以 Oak Tree Engineering, 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。

K220843OAKTREE 前腰椎板及螺釘系統

相關器械（代碼：KWQ）

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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