FDA 510(k)

Optimus ALIF 系統

K 號：K160291 · 2016-02-18

決定日期2016-02-18

產品代碼OVD

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決定相當於

器材摘要

Optimus ALIF System is the device name listed in this FDA 510(k) record. The listed applicant is Amendia, Inc.. It received FDA 510(k) clearance on 2016-02-18 under 510(k) number K160291. 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 Optimus ALIF System?

Optimus ALIF System is a medical device that received FDA 510(k) clearance on 2016-02-18. The listed applicant is Amendia, Inc.. The 510(k) number is K160291.

When did Optimus ALIF System receive FDA 510(k) clearance?

Optimus ALIF System received FDA 510(k) clearance on 2016-02-18, under 510(k) number K160291.

Who is the listed applicant for Optimus ALIF System?

The FDA 510(k) record lists Amendia, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Optimus ALIF System?

The FDA product code for Optimus ALIF System is OVD.

其他以 Amendia, Inc. 為申請人之記錄

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K160924Amendia 間隙融合設備 K161842Overwatch脊椎系統 K152920Savannah-T®脊椎釘系統 K153152齊星穩定系統 K152972Amendia 獨立頸部系統 K151310Amendia 間隙融合設備

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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.

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