FDA 510(k)

脊椎元素固定系統

K 號：K180728 · 2018-09-06

決定日期2018-09-06

產品代碼OWI

諮詢委員會或

決定相當於

器材摘要

Spinal Elements Cerclage System is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Elements, Inc.. It received FDA 510(k) clearance on 2018-09-06 under 510(k) number K180728. 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 Spinal Elements Cerclage System?

Spinal Elements Cerclage System is a medical device that received FDA 510(k) clearance on 2018-09-06. The listed applicant is Spinal Elements, Inc.. The 510(k) number is K180728.

When did Spinal Elements Cerclage System receive FDA 510(k) clearance?

Spinal Elements Cerclage System received FDA 510(k) clearance on 2018-09-06, under 510(k) number K180728.

Who is the listed applicant for Spinal Elements Cerclage System?

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

What is the FDA product code for Spinal Elements Cerclage System?

The FDA product code for Spinal Elements Cerclage System is OWI.

其他以 Spinal Elements, Inc. 為申請人之記錄

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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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