FDA 510(k)

Cure™ 頸前板 (ACP) 系統

K 號：K160604 · 2016-07-01

決定日期2016-07-01

產品代碼KWQ

諮詢委員會或

決定相當於

器材摘要

Cure™ Anterior Cervical Plate (ACP) System is the device name listed in this FDA 510(k) record. The listed applicant is Meditech Spine, LLC. It received FDA 510(k) clearance on 2016-07-01 under 510(k) number K160604. 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 Cure™ Anterior Cervical Plate (ACP) System?

Cure™ Anterior Cervical Plate (ACP) System is a medical device that received FDA 510(k) clearance on 2016-07-01. The listed applicant is Meditech Spine, LLC. The 510(k) number is K160604.

When did Cure™ Anterior Cervical Plate (ACP) System receive FDA 510(k) clearance?

Cure™ Anterior Cervical Plate (ACP) System received FDA 510(k) clearance on 2016-07-01, under 510(k) number K160604.

Who is the listed applicant for Cure™ Anterior Cervical Plate (ACP) System?

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

What is the FDA product code for Cure™ Anterior Cervical Plate (ACP) System?

The FDA product code for Cure™ Anterior Cervical Plate (ACP) System is KWQ.

其他以 Meditech Spine, 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。

K210286治療2.0 頸前板系統 (ACP)K201506Talos®-C 頸椎間盤融合系統，Talos®-C (HA) 頸椎間盤融合系統 K201136Cure™ 腰椎板系統 K181543Cure™ OPEL-C 板系統 K180090Cure™ 腰椎板系統 K171538Cure™ 腰椎板系統

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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

官方來源

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