FDA 510(k)

GetSet外科 GoPLF！後側融合系統

K 號：K202505 · 2021-01-11

決定日期2021-01-11

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

GetSet Surgical GoPLF! Posterior Lateral Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Getset Surgical, SA. It received FDA 510(k) clearance on 2021-01-11 under 510(k) number K202505. 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 GetSet Surgical GoPLF! Posterior Lateral Fusion System?

GetSet Surgical GoPLF! Posterior Lateral Fusion System is a medical device that received FDA 510(k) clearance on 2021-01-11. The listed applicant is Getset Surgical, SA. The 510(k) number is K202505.

When did GetSet Surgical GoPLF! Posterior Lateral Fusion System receive FDA 510(k) clearance?

GetSet Surgical GoPLF! Posterior Lateral Fusion System received FDA 510(k) clearance on 2021-01-11, under 510(k) number K202505.

Who is the listed applicant for GetSet Surgical GoPLF! Posterior Lateral Fusion System?

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

What is the FDA product code for GetSet Surgical GoPLF! Posterior Lateral Fusion System?

The FDA product code for GetSet Surgical GoPLF! Posterior Lateral Fusion System is NKB.

其他以 Getset Surgical, SA 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。

K250186GoLIF! 腰椎間融合系統

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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