FDA 510(k)

維斯賓™ 維拉姆™ 樂氏成形系統

K 號：K242784 · 2024-10-16

決定日期2024-10-16

產品代碼NQW

諮詢委員會或

決定相當於

器材摘要

Vy Spine™ VyLam™ Laminoplasty System is the device name listed in this FDA 510(k) record. The listed applicant is Vy Spine, LLC. It received FDA 510(k) clearance on 2024-10-16 under 510(k) number K242784. The device is classified under product code NQW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Vy Spine™ VyLam™ Laminoplasty System?

Vy Spine™ VyLam™ Laminoplasty System is a medical device that received FDA 510(k) clearance on 2024-10-16. The listed applicant is Vy Spine, LLC. The 510(k) number is K242784.

When did Vy Spine™ VyLam™ Laminoplasty System receive FDA 510(k) clearance?

Vy Spine™ VyLam™ Laminoplasty System received FDA 510(k) clearance on 2024-10-16, under 510(k) number K242784.

Who is the listed applicant for Vy Spine™ VyLam™ Laminoplasty System?

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

What is the FDA product code for Vy Spine™ VyLam™ Laminoplasty System?

The FDA product code for Vy Spine™ VyLam™ Laminoplasty System is NQW.

其他以 Vy 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。

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相關器械（代碼：NQW）

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。

K252930AQUA Laminoplasty SystemsZheJiang Decans Medical Devices Co., Ltd.K243137Curiteva多孔PEEK椎板成形系統Curiteva, Inc.K232471維斯賓™ 維拉姆™ 樂氏成形系統Vy Spine, LLC K231232Curiteva 樂林術系統Curiteva, Inc.K212428中心板固定系統Medtronic Sofamor Danek K191927關節式椎板成形術系統Life Spine, Inc.

官方來源

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