FDA 510(k)

HD LifeSciences 頸部IBFD系統

K 號：K180364 · 2018-06-27

決定日期2018-06-27

產品代碼ODP

諮詢委員會或

決定相當於

器材摘要

HD LifeSciences Cervical IBFD System is the device name listed in this FDA 510(k) record. The listed applicant is Hd Lifesciences, LLC. It received FDA 510(k) clearance on 2018-06-27 under 510(k) number K180364. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HD LifeSciences Cervical IBFD System?

HD LifeSciences Cervical IBFD System is a medical device that received FDA 510(k) clearance on 2018-06-27. The listed applicant is Hd Lifesciences, LLC. The 510(k) number is K180364.

When did HD LifeSciences Cervical IBFD System receive FDA 510(k) clearance?

HD LifeSciences Cervical IBFD System received FDA 510(k) clearance on 2018-06-27, under 510(k) number K180364.

Who is the listed applicant for HD LifeSciences Cervical IBFD System?

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

What is the FDA product code for HD LifeSciences Cervical IBFD System?

The FDA product code for HD LifeSciences Cervical IBFD System is ODP.

其他以 Hd Lifesciences, LLC 為申請人之記錄

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相關器械（代碼：ODP）

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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