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FDA 510(k)

INLIANT 外科導航系統

K 號：K213392 · 2022-02-22

申請人Navigate Surgical Technologies, Inc.
決定日期2022-02-22
產品代碼PLV
諮詢委員會DE
決定相當於

器材摘要

INLIANT Surgical Navigation System is the device name listed in this FDA 510(k) record. The listed applicant is Navigate Surgical Technologies, Inc.. It received FDA 510(k) clearance on 2022-02-22 under 510(k) number K213392. The device is classified under product code PLV. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the INLIANT Surgical Navigation System?

INLIANT Surgical Navigation System is a medical device that received FDA 510(k) clearance on 2022-02-22. The listed applicant is Navigate Surgical Technologies, Inc.. The 510(k) number is K213392.

When did INLIANT Surgical Navigation System receive FDA 510(k) clearance?

INLIANT Surgical Navigation System received FDA 510(k) clearance on 2022-02-22, under 510(k) number K213392.

Who is the listed applicant for INLIANT Surgical Navigation System?

The FDA 510(k) record lists Navigate Surgical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INLIANT Surgical Navigation System?

The FDA product code for INLIANT Surgical Navigation System is PLV.

相關臨床試驗

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：PLV）

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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