FDA 510(k)

STYLO 間隙融合設備

K 號：K180071 · 2018-05-03

決定日期2018-05-03

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

STYLO Interbody Fusion Device is the device name listed in this FDA 510(k) record. The listed applicant is Legend Spine Technologies. It received FDA 510(k) clearance on 2018-05-03 under 510(k) number K180071. 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 STYLO Interbody Fusion Device?

STYLO Interbody Fusion Device is a medical device that received FDA 510(k) clearance on 2018-05-03. The listed applicant is Legend Spine Technologies. The 510(k) number is K180071.

When did STYLO Interbody Fusion Device receive FDA 510(k) clearance?

STYLO Interbody Fusion Device received FDA 510(k) clearance on 2018-05-03, under 510(k) number K180071.

Who is the listed applicant for STYLO Interbody Fusion Device?

The FDA 510(k) record lists Legend Spine Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STYLO Interbody Fusion Device?

The FDA product code for STYLO Interbody Fusion Device is MAX.

其他以 Legend Spine Technologies 為申請人之記錄

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K192208CORNICE 頸椎間隔系統

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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