FDA 510(k)

FlexitSystem 適應性膝關節截骨系統

K 號：K212545 · 2022-02-11

決定日期2022-02-11

產品代碼HRS

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決定相當於

器材摘要

FlexitSystem Knee osteotomy system is the device name listed in this FDA 510(k) record. The listed applicant is Neosteo. It received FDA 510(k) clearance on 2022-02-11 under 510(k) number K212545. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FlexitSystem Knee osteotomy system?

FlexitSystem Knee osteotomy system is a medical device that received FDA 510(k) clearance on 2022-02-11. The listed applicant is Neosteo. The 510(k) number is K212545.

When did FlexitSystem Knee osteotomy system receive FDA 510(k) clearance?

FlexitSystem Knee osteotomy system received FDA 510(k) clearance on 2022-02-11, under 510(k) number K212545.

Who is the listed applicant for FlexitSystem Knee osteotomy system?

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

What is the FDA product code for FlexitSystem Knee osteotomy system?

The FDA product code for FlexitSystem Knee osteotomy system is HRS.

其他以 Neosteo 為申請人之記錄

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K192447超彈性釘針 K191424指間關節融合設備範圍

相關器械（代碼：HRS）

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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