FDA 510(k)

LigaPASS®脊椎系統，CD Horizon™脊椎系統

K 號：K211057 · 2021-05-27

決定日期2021-05-27

產品代碼OWI

諮詢委員會或

決定相當於

器材摘要

LigaPASS® Spinal System, CD Horizon™ Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2021-05-27 under 510(k) number K211057. The device is classified under product code OWI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LigaPASS® Spinal System, CD Horizon™ Spinal System?

LigaPASS® Spinal System, CD Horizon™ Spinal System is a medical device that received FDA 510(k) clearance on 2021-05-27. The listed applicant is Medtronic, Inc.. The 510(k) number is K211057.

When did LigaPASS® Spinal System, CD Horizon™ Spinal System receive FDA 510(k) clearance?

LigaPASS® Spinal System, CD Horizon™ Spinal System received FDA 510(k) clearance on 2021-05-27, under 510(k) number K211057.

Who is the listed applicant for LigaPASS® Spinal System, CD Horizon™ Spinal System?

FDA 510(k) 記錄將美敦力公司（Medtronic, Inc.）列為申請人。這並不單獨確立該設備製造商。

What is the FDA product code for LigaPASS® Spinal System, CD Horizon™ Spinal System?

The FDA product code for LigaPASS® Spinal System, CD Horizon™ Spinal System is OWI.

其他以 Medtronic, Inc. 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：OWI）

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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