FDA 510(k)

Salvo®脊椎系統

K 號：K240685 · 2024-05-06

決定日期2024-05-06

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

Salvo® Spine System is the device name listed in this FDA 510(k) record. The listed applicant is Spine Wave, Inc.. It received FDA 510(k) clearance on 2024-05-06 under 510(k) number K240685. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Salvo® Spine System?

Salvo® Spine System is a medical device that received FDA 510(k) clearance on 2024-05-06. The listed applicant is Spine Wave, Inc.. The 510(k) number is K240685.

When did Salvo® Spine System receive FDA 510(k) clearance?

Salvo® Spine System received FDA 510(k) clearance on 2024-05-06, under 510(k) number K240685.

Who is the listed applicant for Salvo® Spine System?

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

What is the FDA product code for Salvo® Spine System?

The FDA product code for Salvo® Spine System is NKB.

其他以 Spine Wave, Inc. 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。

K260286Dynamo™脊椎水泥；Salvo®脊椎系統 K261159Exceed®雙平面擴張式椎間融合系統 K243816Testa TP 旋轉間隔系統 K251131Annex® 2 邻近層級系統 K243514Salvo®機器人導航儀器 K231275Exceed™雙平面擴展式椎間融合系統

查看所有 24 項裝置 →

相關器械（代碼：NKB）

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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官方來源

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