FDA 510(k)

Altus Spine 頸椎板系統

K 號：K163061 · 2017-02-06

決定日期2017-02-06

產品代碼KWQ

諮詢委員會或

決定相當於

器材摘要

Altus Spine Cervical Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Altus Partners, LLC. It received FDA 510(k) clearance on 2017-02-06 under 510(k) number K163061. 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 Altus Spine Cervical Plate System?

Altus Spine Cervical Plate System is a medical device that received FDA 510(k) clearance on 2017-02-06. The listed applicant is Altus Partners, LLC. The 510(k) number is K163061.

When did Altus Spine Cervical Plate System receive FDA 510(k) clearance?

Altus Spine Cervical Plate System received FDA 510(k) clearance on 2017-02-06, under 510(k) number K163061.

Who is the listed applicant for Altus Spine Cervical Plate System?

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

What is the FDA product code for Altus Spine Cervical Plate System?

The FDA product code for Altus Spine Cervical Plate System is KWQ.

其他以 Altus Partners, 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。

K243419Altus Spine 導航系統 K211027Altus Spine 椎弓釘系統 K211837Altus Spine 間融合獨立系統 K210887Altus Spine Sochi OCT 腰椎系統 K200922Altus Spine HA 椎弓釘系統 K200322Altus Spine 椎弓釘系統

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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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