FDA 510(k)

快速外科計劃 (RSP-SW-001)

K 號：K243447 · 2024-12-05

決定日期2024-12-05

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

Rapid Surgical Plan (RSP-SW-001) is the device name listed in this FDA 510(k) record. The listed applicant is Navbit Pty, Ltd.. It received FDA 510(k) clearance on 2024-12-05 under 510(k) number K243447. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Rapid Surgical Plan (RSP-SW-001)?

Rapid Surgical Plan (RSP-SW-001) is a medical device that received FDA 510(k) clearance on 2024-12-05. The listed applicant is Navbit Pty, Ltd.. The 510(k) number is K243447.

When did Rapid Surgical Plan (RSP-SW-001) receive FDA 510(k) clearance?

Rapid Surgical Plan (RSP-SW-001) received FDA 510(k) clearance on 2024-12-05, under 510(k) number K243447.

Who is the listed applicant for Rapid Surgical Plan (RSP-SW-001)?

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

What is the FDA product code for Rapid Surgical Plan (RSP-SW-001)?

The FDA product code for Rapid Surgical Plan (RSP-SW-001) is LLZ.

其他以 Navbit Pty, Ltd. 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。

K200376Navbit Sprint 系統- 仰臥註冊，Navbit Sprint 套件 - 旁邊註冊

相關器械（代碼：LLZ）

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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