FDA 510(k)

CATAMARAN™ 骨盆聯合融合系統

K 號：K260477 · 2026-04-08

決定日期2026-04-08

產品代碼OUR

諮詢委員會或

決定相當於

器材摘要

CATAMARAN™ SI Joint Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Tenon Medical. It received FDA 510(k) clearance on 2026-04-08 under 510(k) number K260477. 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 CATAMARAN™ SI Joint Fusion System?

CATAMARAN™ SI Joint Fusion System is a medical device that received FDA 510(k) clearance on 2026-04-08. The listed applicant is Tenon Medical. The 510(k) number is K260477.

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

CATAMARAN™ SI Joint Fusion System received FDA 510(k) clearance on 2026-04-08, under 510(k) number K260477.

Who is the listed applicant for CATAMARAN™ SI Joint Fusion System?

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

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

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

其他以 Tenon Medical 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。

K250403貓鷹 SI關節融合系統

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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