FDA 510(k)

RODIN™可擴展腰椎籠架系統

K 號：K231359 · 2023-06-09

決定日期2023-06-09

產品代碼MAX

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決定相當於

器材摘要

RODIN™ Expandable Lumbar Cage System is the device name listed in this FDA 510(k) record. The listed applicant is Ctl Medical Corporation. It received FDA 510(k) clearance on 2023-06-09 under 510(k) number K231359. 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 RODIN™ Expandable Lumbar Cage System?

RODIN™ Expandable Lumbar Cage System is a medical device that received FDA 510(k) clearance on 2023-06-09. The listed applicant is Ctl Medical Corporation. The 510(k) number is K231359.

When did RODIN™ Expandable Lumbar Cage System receive FDA 510(k) clearance?

RODIN™ Expandable Lumbar Cage System received FDA 510(k) clearance on 2023-06-09, under 510(k) number K231359.

Who is the listed applicant for RODIN™ Expandable Lumbar Cage System?

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

What is the FDA product code for RODIN™ Expandable Lumbar Cage System?

The FDA product code for RODIN™ Expandable Lumbar Cage System is MAX.

其他以 Ctl Medical Corporation 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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官方來源

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