FDA 510(k)

TiLock 模組化脊椎系統

K 號：K172469 · 2017-11-30

決定日期2017-11-30

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

TiLock Modular Spinal 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 2017-11-30 under 510(k) number K172469. 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 TiLock Modular Spinal System?

TiLock Modular Spinal System is a medical device that received FDA 510(k) clearance on 2017-11-30. The listed applicant is Genesys Spine. The 510(k) number is K172469.

When did TiLock Modular Spinal System receive FDA 510(k) clearance?

TiLock Modular Spinal System received FDA 510(k) clearance on 2017-11-30, under 510(k) number K172469.

Who is the listed applicant for TiLock Modular Spinal 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 TiLock Modular Spinal System?

The FDA product code for TiLock Modular Spinal System is NKB.

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：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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