FDA 510(k)

ENZA-A 鈦金屬 ALIF

K 號：K173432 · 2018-04-18

決定日期2018-04-18

產品代碼OVD

諮詢委員會或

決定相當於

器材摘要

ENZA-A Titanium 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 2018-04-18 under 510(k) number K173432. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ENZA-A Titanium ALIF?

ENZA-A Titanium ALIF is a medical device that received FDA 510(k) clearance on 2018-04-18. The listed applicant is Camber Spine Technologies. The 510(k) number is K173432.

When did ENZA-A Titanium ALIF receive FDA 510(k) clearance?

ENZA-A Titanium ALIF received FDA 510(k) clearance on 2018-04-18, under 510(k) number K173432.

Who is the listed applicant for ENZA-A Titanium 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 ENZA-A Titanium ALIF?

The FDA product code for ENZA-A Titanium ALIF is OVD.

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：OVD）

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。

K262025Innovasis AxTiHA® 独立式 ALIF 系統；Innovasis TxTiHA® IBF 系統；Innovasis HAtetracell®-C 鈦金屬頸椎 IBF 系統INNO Holdings Inc. DBA Innovasis K261408SABER-XA 系統Elevation Spine K261809Interwedge® 独立側邊架Foundation Surgical Group K261353泰瑟拉-K 前腰椎間融合（ALIF）系統；泰瑟拉-K XL 系統；腰椎固定系統Kyocera Medical Technologies, Inc.K260810Anteralign LS 盖板Tyber Medical, LLC K254202MectaLIF 3D金屬前臍Medacta International S.A.

官方來源

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