FDA 510(k)

panaSIa SI 融合系統

K 號：K250247 · 2025-07-09

決定日期2025-07-09

產品代碼OUR

諮詢委員會或

決定相當於

器材摘要

panaSIa SI Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Wenzel Spine, Inc.. It received FDA 510(k) clearance on 2025-07-09 under 510(k) number K250247. 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 panaSIa SI Fusion System?

panaSIa SI Fusion System is a medical device that received FDA 510(k) clearance on 2025-07-09. The listed applicant is Wenzel Spine, Inc.. The 510(k) number is K250247.

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

panaSIa SI Fusion System received FDA 510(k) clearance on 2025-07-09, under 510(k) number K250247.

Who is the listed applicant for panaSIa SI Fusion System?

FDA 510(k) 記錄將 Wenzel Spine, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for panaSIa SI Fusion System?

The FDA product code for panaSIa SI Fusion System is OUR.

其他以 Wenzel Spine, Inc. 為申請人之記錄

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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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