FDA 510(k)

ZESPIN 門關融合系統

K 號：K223521 · 2023-01-20

決定日期2023-01-20

產品代碼OUR

諮詢委員會或

決定相當於

器材摘要

ZESPIN SI Joint Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Aegis Spine, Inc.. It received FDA 510(k) clearance on 2023-01-20 under 510(k) number K223521. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ZESPIN SI Joint Fusion System?

ZESPIN SI Joint Fusion System is a medical device that received FDA 510(k) clearance on 2023-01-20. The listed applicant is Aegis Spine, Inc.. The 510(k) number is K223521.

When did ZESPIN SI Joint Fusion System receive FDA 510(k) clearance?

ZESPIN SI Joint Fusion System received FDA 510(k) clearance on 2023-01-20, under 510(k) number K223521.

Who is the listed applicant for ZESPIN SI Joint Fusion System?

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

What is the FDA product code for ZESPIN SI Joint Fusion System?

The FDA product code for ZESPIN SI Joint Fusion System is OUR.

其他以 Aegis Spine, Inc. 為申請人之記錄

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K223719牡丹前頸板系統，Elatus腰板系統 K221719ABTross ALIF 可擴展金屬籠系統 K221050ZESPIN 間盤融合系統，白芍後頸固定系統，白芍前頸板系統，Spinema 腰椎板系統 K203531XYPAN可擴展腰椎籠架系統

相關器械（代碼：OUR）

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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