FDA 510(k)

Rexious脊椎固定系統，Statera™脊椎系統，Statera-M™脊椎系統

K 號：K232586 · 2023-10-24

決定日期2023-10-24

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is K&J Consulting Corp.. It received FDA 510(k) clearance on 2023-10-24 under 510(k) number K232586. 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 Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System?

Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System is a medical device that received FDA 510(k) clearance on 2023-10-24. The listed applicant is K&J Consulting Corp.. The 510(k) number is K232586.

When did Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System receive FDA 510(k) clearance?

Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System received FDA 510(k) clearance on 2023-10-24, under 510(k) number K232586.

Who is the listed applicant for Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System?

The FDA 510(k) record lists K&J Consulting Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System?

The FDA product code for Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System is NKB.

其他以 K&J Consulting Corp. 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。

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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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