FDA 510(k)

脊椎元素Ti-Bond涂層設備

K 號：K181837 · 2018-11-02

決定日期2018-11-02

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

Spinal Elements Ti-Bond coated devices 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 2018-11-02 under 510(k) number K181837. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Spinal Elements Ti-Bond coated devices?

Spinal Elements Ti-Bond coated devices is a medical device that received FDA 510(k) clearance on 2018-11-02. The listed applicant is Spinal Elements, Inc.. The 510(k) number is K181837.

When did Spinal Elements Ti-Bond coated devices receive FDA 510(k) clearance?

Spinal Elements Ti-Bond coated devices received FDA 510(k) clearance on 2018-11-02, under 510(k) number K181837.

Who is the listed applicant for Spinal Elements Ti-Bond coated devices?

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 Ti-Bond coated devices?

The FDA product code for Spinal Elements Ti-Bond coated devices is MAX.

其他以 Spinal Elements, Inc. 為申請人之記錄

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相關器械（代碼：MAX）

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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