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FDA 510(k)

StealthStation 棘突過程夾具

K 號:K211442 · 2021-07-08

決定日期2021-07-08
產品代碼OLO
諮詢委員會NE (請提供完整的英文描述,以便進行翻譯。)
決定相當於

器材摘要

StealthStation Spinous Process Clamps is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Navigation. It received FDA 510(k) clearance on 2021-07-08 under 510(k) number K211442. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the StealthStation Spinous Process Clamps?

StealthStation Spinous Process Clamps is a medical device that received FDA 510(k) clearance on 2021-07-08. The listed applicant is Medtronic Navigation. The 510(k) number is K211442.

When did StealthStation Spinous Process Clamps receive FDA 510(k) clearance?

StealthStation Spinous Process Clamps received FDA 510(k) clearance on 2021-07-08, under 510(k) number K211442.

Who is the listed applicant for StealthStation Spinous Process Clamps?

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

What is the FDA product code for StealthStation Spinous Process Clamps?

The FDA product code for StealthStation Spinous Process Clamps is OLO.

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其他以 Medtronic Navigation 為申請人之記錄

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相關器械(代碼:OLO)

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。

官方來源

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