FDA 510(k)

SECULOK™ ACP 系統

K 號：K182055 · 2018-09-10

決定日期2018-09-10

產品代碼KWQ

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決定相當於

器材摘要

SECULOK™ ACP System is the device name listed in this FDA 510(k) record. The listed applicant is U&I Corporation. It received FDA 510(k) clearance on 2018-09-10 under 510(k) number K182055. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SECULOK™ ACP System?

SECULOK™ ACP System is a medical device that received FDA 510(k) clearance on 2018-09-10. The listed applicant is U&I Corporation. The 510(k) number is K182055.

When did SECULOK™ ACP System receive FDA 510(k) clearance?

SECULOK™ ACP System received FDA 510(k) clearance on 2018-09-10, under 510(k) number K182055.

Who is the listed applicant for SECULOK™ ACP System?

The FDA 510(k) record lists U&I Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SECULOK™ ACP System?

The FDA product code for SECULOK™ ACP System is KWQ.

其他以 U&I Corporation 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。

K220147Aspiron S ACP 系統 K210573維洛菲克斯SA頸椎籠 K183243維洛菲克斯TLIF金屬支架 K190067維洛菲克斯內固定融合系統 K190053SECULOK™ ACP 系統 K181824CBT 螺釘固定系統

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相關器械（代碼：KWQ）

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。

K262149corra®脊椎板系統Carlsmed, Inc.K261309Palisades™ 壁壘板系統Bethesda Medical Devices, LLC K252776ARIES 前頸椎板系統ZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P 頸椎前方板系統L&K BIOMED Co., Ltd.K260570corra™脊椎板系統Carlsmed, Inc.K260697VyPlate™ 頸椎前方板系統Vy Spine, LLC

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