FDA 510(k)

Momentum® MIS脊椎後固定系統

K 號：K223274 · 2022-11-28

決定日期2022-11-28

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

Momentum® MIS Posterior Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Ulrich Medical USA. It received FDA 510(k) clearance on 2022-11-28 under 510(k) number K223274. 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 Momentum® MIS Posterior Spinal Fixation System?

Momentum® MIS Posterior Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2022-11-28. The listed applicant is Ulrich Medical USA. The 510(k) number is K223274.

When did Momentum® MIS Posterior Spinal Fixation System receive FDA 510(k) clearance?

Momentum® MIS Posterior Spinal Fixation System received FDA 510(k) clearance on 2022-11-28, under 510(k) number K223274.

Who is the listed applicant for Momentum® MIS Posterior Spinal Fixation System?

The FDA 510(k) record lists Ulrich Medical USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Momentum® MIS Posterior Spinal Fixation System?

The FDA product code for Momentum® MIS Posterior Spinal Fixation System is NKB.

其他以 Ulrich Medical USA 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。

K231809Momentum® 頸後脊椎固定系統搭配 G21 V-STEADY 骨水泥；Momentum® MIS 頸後脊椎固定系統搭配 G21 V-STEADY 骨水泥 K230614Cortium™K220696uCerv Flux-C 3D多孔钛颈椎間植體 K200845動力系統導航模組 K191932動力™ 頸椎後固定系統 K181921固體椎體置換器

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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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