FDA 510(k)

SPIRA 開放式矩陣 ALIF

K 號：K162986 · 2017-06-12

決定日期2017-06-12

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

SPIRA Open Matrix ALIF is the device name listed in this FDA 510(k) record. The listed applicant is Camber Spine Technologies. It received FDA 510(k) clearance on 2017-06-12 under 510(k) number K162986. 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 ALIF?

SPIRA Open Matrix ALIF is a medical device that received FDA 510(k) clearance on 2017-06-12. The listed applicant is Camber Spine Technologies. The 510(k) number is K162986.

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

SPIRA Open Matrix ALIF received FDA 510(k) clearance on 2017-06-12, under 510(k) number K162986.

Who is the listed applicant for SPIRA Open Matrix ALIF?

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

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

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

其他以 Camber Spine Technologies 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。

K234077SPIRA® 前腰椎間隔器 K233972Camber 骨盆釘定系統 K230942SPIRA® 腰椎後部間隔器 K221324ENZA-O 鈦金屬側前方腰椎間融合術（ALIF）K223837SPIRA®-C 整合固定系統 K220038Camber脊椎導航系統

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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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