FDA 510(k)

HARRIER-SA™ 腰椎間盤系統

K 號：K180519 · 2018-05-16

決定日期2018-05-16

產品代碼OVD

諮詢委員會或

決定相當於

器材摘要

HARRIER-SA™ Lumbar Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Choicespine, LP. It received FDA 510(k) clearance on 2018-05-16 under 510(k) number K180519. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HARRIER-SA™ Lumbar Interbody System?

HARRIER-SA™ Lumbar Interbody System is a medical device that received FDA 510(k) clearance on 2018-05-16. The listed applicant is Choicespine, LP. The 510(k) number is K180519.

When did HARRIER-SA™ Lumbar Interbody System receive FDA 510(k) clearance?

HARRIER-SA™ Lumbar Interbody System received FDA 510(k) clearance on 2018-05-16, under 510(k) number K180519.

Who is the listed applicant for HARRIER-SA™ Lumbar Interbody System?

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

What is the FDA product code for HARRIER-SA™ Lumbar Interbody System?

The FDA product code for HARRIER-SA™ Lumbar Interbody System is OVD.

其他以 Choicespine, LP 為申請人之記錄

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相關器械（代碼：OVD）

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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