FDA 510(k)

Genesys Spine Binary® 腰椎板系統

K 號：K192678 · 2019-10-24

決定日期2019-10-24

產品代碼KWQ

諮詢委員會或

決定相當於

器材摘要

Genesys Spine Binary® Lumbar Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Genesys Spine. It received FDA 510(k) clearance on 2019-10-24 under 510(k) number K192678. 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 Genesys Spine Binary® Lumbar Plate System?

Genesys Spine Binary® Lumbar Plate System is a medical device that received FDA 510(k) clearance on 2019-10-24. The listed applicant is Genesys Spine. The 510(k) number is K192678.

When did Genesys Spine Binary® Lumbar Plate System receive FDA 510(k) clearance?

Genesys Spine Binary® Lumbar Plate System received FDA 510(k) clearance on 2019-10-24, under 510(k) number K192678.

Who is the listed applicant for Genesys Spine Binary® Lumbar Plate System?

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

What is the FDA product code for Genesys Spine Binary® Lumbar Plate System?

The FDA product code for Genesys Spine Binary® Lumbar Plate System is KWQ.

其他以 Genesys Spine 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。

K252322西羅斯-X系統 K242483Genesys脊椎AIS-C II頸椎間融合系統 K233595Genesys脊椎骨盆關節融合系統配導航 K233594Genesys Spine 3DP AIS-C II 頸椎間盤系統 K220096Genesys Spine 3DP 腰椎間盤系統 K191489Genesys脊椎3DP頸椎間盤系統

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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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