FDA 510(k)

Sapphire®脊椎系統，Sapphire X 前頸椎板脊椎系統

K 號：K201029 · 2020-06-17

決定日期2020-06-17

產品代碼KWQ

諮詢委員會或

決定相當於

器材摘要

Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal 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 2020-06-17 under 510(k) number K201029. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System?

Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System is a medical device that received FDA 510(k) clearance on 2020-06-17. The listed applicant is Spinal Elements, Inc.. The 510(k) number is K201029.

When did Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System receive FDA 510(k) clearance?

Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System received FDA 510(k) clearance on 2020-06-17, under 510(k) number K201029.

Who is the listed applicant for Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal 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 Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System?

The FDA product code for Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System is KWQ.

其他以 Spinal Elements, Inc. 為申請人之記錄

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相關器械（代碼：KWQ）

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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