FDA 510(k)

TITAN 3-D 角楔系統

K 號：K231496 · 2023-08-22

決定日期2023-08-22

產品代碼PLF

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決定相當於

器材摘要

TITAN 3-D Wedge System is the device name listed in this FDA 510(k) record. The listed applicant is Paragon 28, Inc.. It received FDA 510(k) clearance on 2023-08-22 under 510(k) number K231496. The device is classified under product code PLF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TITAN 3-D Wedge System?

TITAN 3-D Wedge System is a medical device that received FDA 510(k) clearance on 2023-08-22. The listed applicant is Paragon 28, Inc.. The 510(k) number is K231496.

When did TITAN 3-D Wedge System receive FDA 510(k) clearance?

TITAN 3-D Wedge System received FDA 510(k) clearance on 2023-08-22, under 510(k) number K231496.

Who is the listed applicant for TITAN 3-D Wedge System?

FDA 510(k) 記錄將 Paragon 28, 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 TITAN 3-D Wedge System?

The FDA product code for TITAN 3-D Wedge System is PLF.

其他以 Paragon 28, Inc. 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。

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相關器械（代碼：PLF）

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。

K252733ATLAS™ Expandable Osteotomy Wedge SystemMiRus, LLC K252254骨切楔形系統Sinaptic Surgical K251791Auxano® 極板固定系統Auxano Medical, LLC K240461OsteoSinter® EVANS 與 COTTON 塊及相關配件Ames Medical Prosthetic Solutions, S.A.U.K243231三角PEEK HA楔子Nvision Biomedical Technologies K234116Trigon Trigon HA 独立楔形固定系統Nvision Biomedical Technologies

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