FDA 510(k)

SPIRA 開放矩陣 LLIF

K 號：K180724 · 2018-06-25

決定日期2018-06-25

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

SPIRA Open Matrix LLIF is the device name listed in this FDA 510(k) record. The listed applicant is Camber Spine Technologies, LLC. It received FDA 510(k) clearance on 2018-06-25 under 510(k) number K180724. 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 SPIRA Open Matrix LLIF?

SPIRA Open Matrix LLIF is a medical device that received FDA 510(k) clearance on 2018-06-25. The listed applicant is Camber Spine Technologies, LLC. The 510(k) number is K180724.

When did SPIRA Open Matrix LLIF receive FDA 510(k) clearance?

SPIRA Open Matrix LLIF received FDA 510(k) clearance on 2018-06-25, under 510(k) number K180724.

Who is the listed applicant for SPIRA Open Matrix LLIF?

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

What is the FDA product code for SPIRA Open Matrix LLIF?

The FDA product code for SPIRA Open Matrix LLIF is MAX.

其他以 Camber Spine Technologies, LLC 為申請人之記錄

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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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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