FDA 510(k)

Salvo®脊椎系統

K 號：K222362 · 2022-08-29

決定日期2022-08-29

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 2022-08-29 under 510(k) number K222362. 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 2022-08-29. The listed applicant is Spine Wave, Inc.. The 510(k) number is K222362.

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

Salvo® Spine System received FDA 510(k) clearance on 2022-08-29, under 510(k) number K222362.

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 K240685Salvo®脊椎系統

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。

K252139肯特羅斯賓 Viktr-MIS® 椎板螺釘系統Rivarp Medical Pvt., Ltd.K262067iFuse Granite Onyx™ 假骨植入系統SI-BONE, Inc.K262091FRAXION脊椎固定系統Ortler Global Tibbi Gerecler Anonim Sirketi K262193RIVA® 後固定系統搭配NanoACTIV表面技術；RIVA® 髋骨結合固定釘搭配NanoACTIV表面技術Xenix Medical K262828KHEIRON®脊椎固定系統，包括客製化K-RODS.M.A.I.O K260362QUATTRO脊椎系統（開放配置）；QUATTRO-GADGET脊椎系統（MIS配置）MANTIZ Co., Ltd.

官方來源

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