FDA 510(k)

FORZA XP 可擴展間隔系統

K 號：K213951 · 2022-01-05

決定日期2022-01-05

產品代碼MAX

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決定相當於

器材摘要

FORZA XP Expandable Spacer System is the device name listed in this FDA 510(k) record. The listed applicant is Orthofix US, LLC. It received FDA 510(k) clearance on 2022-01-05 under 510(k) number K213951. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FORZA XP Expandable Spacer System?

FORZA XP Expandable Spacer System is a medical device that received FDA 510(k) clearance on 2022-01-05. The listed applicant is Orthofix US, LLC. The 510(k) number is K213951.

When did FORZA XP Expandable Spacer System receive FDA 510(k) clearance?

FORZA XP Expandable Spacer System received FDA 510(k) clearance on 2022-01-05, under 510(k) number K213951.

Who is the listed applicant for FORZA XP Expandable Spacer System?

The FDA 510(k) record lists Orthofix US, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FORZA XP Expandable Spacer System?

The FDA product code for FORZA XP Expandable Spacer System is MAX.

其他以 Orthofix US, LLC 為申請人之記錄

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相關器械（代碼：MAX）

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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