FDA 510(k)

固體椎體置換器

K 號：K181921 · 2018-11-16

決定日期2018-11-16

產品代碼MQP

諮詢委員會或

決定相當於

器材摘要

Solidity Vertebral Body Replacement is the device name listed in this FDA 510(k) record. The listed applicant is Ulrich Medical USA. It received FDA 510(k) clearance on 2018-11-16 under 510(k) number K181921. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Solidity Vertebral Body Replacement?

Solidity Vertebral Body Replacement is a medical device that received FDA 510(k) clearance on 2018-11-16. The listed applicant is Ulrich Medical USA. The 510(k) number is K181921.

When did Solidity Vertebral Body Replacement receive FDA 510(k) clearance?

Solidity Vertebral Body Replacement received FDA 510(k) clearance on 2018-11-16, under 510(k) number K181921.

Who is the listed applicant for Solidity Vertebral Body Replacement?

The FDA 510(k) record lists Ulrich Medical USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Solidity Vertebral Body Replacement?

The FDA product code for Solidity Vertebral Body Replacement is MQP.

其他以 Ulrich Medical USA 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。

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相關器械（代碼：MQP）

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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