FDA 510(k)

TiLink-P 骨盆聯合融合系統

K 號：K243835 · 2024-12-27

決定日期2024-12-27

產品代碼OUR

諮詢委員會或

決定相當於

器材摘要

TiLink-P SI Joint Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is SurGenTec, LLC. It received FDA 510(k) clearance on 2024-12-27 under 510(k) number K243835. 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 TiLink-P SI Joint Fusion System?

TiLink-P SI Joint Fusion System is a medical device that received FDA 510(k) clearance on 2024-12-27. The listed applicant is SurGenTec, LLC. The 510(k) number is K243835.

When did TiLink-P SI Joint Fusion System receive FDA 510(k) clearance?

TiLink-P SI Joint Fusion System received FDA 510(k) clearance on 2024-12-27, under 510(k) number K243835.

Who is the listed applicant for TiLink-P SI Joint Fusion System?

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

What is the FDA product code for TiLink-P SI Joint Fusion System?

The FDA product code for TiLink-P SI Joint Fusion System is OUR.

其他以 SurGenTec, LLC 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。

K252995杜拉盾設備套件 K262581GraftGun 適用性移植輸送系統 (GDS®)K261381TiLink-L™ 骨盆聯合融合系統 K262121離子-L導航儀器 K261209離子-L (注意：原文中 "device_name" 和 "medical-device regulatory text" 沒有提供完整的內容，因此只能根據 "Ion-L" 進行翻譯。如果需要完整的翻譯，請提供完整的文本。)K260329離子導航儀器

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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。

K261381TiLink-L™ 骨盆聯合融合系統SurGenTec, LLC K260477CATAMARAN™ 骨盆聯合融合系統Tenon Medical K253488iFuse INTRA Ti™ 嵌入系統SI-BONE, Inc.K253611鷹融合系統Mcnicoll Surgical, Inc.K252834骨盆釘合系統 (SJTS)4Web Medical K251365OptumSI 嵌入式系統Si Solutions, LLC

官方來源

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