FDA 510(k)

LineSider®脊椎系統

K 號：K231098 · 2023-08-07

決定日期2023-08-07

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

LineSider® Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Integrity Implants, Inc.. It received FDA 510(k) clearance on 2023-08-07 under 510(k) number K231098. 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 LineSider® Spinal System?

LineSider® Spinal System is a medical device that received FDA 510(k) clearance on 2023-08-07. The listed applicant is Integrity Implants, Inc.. The 510(k) number is K231098.

When did LineSider® Spinal System receive FDA 510(k) clearance?

LineSider® Spinal System received FDA 510(k) clearance on 2023-08-07, under 510(k) number K231098.

Who is the listed applicant for LineSider® Spinal System?

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

What is the FDA product code for LineSider® Spinal System?

The FDA product code for LineSider® Spinal System is NKB.

其他以 Integrity Implants, 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。

K213355托羅-L 間體融合系統 K220453FlareHawk 間隙融合系統 K212088Integrity Implants 精準導向儀器 K203038托羅-L 間體融合系統 K203367LineSider™脊椎系統 K202198FlareHawk 間隙融合系統

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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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