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FDA 510(k)

OsteoSinter® EVANS 與 COTTON 塊及相關配件

K 號：K240461 · 2024-12-06

申請人Ames Medical Prosthetic Solutions, S.A.U.
決定日期2024-12-06
產品代碼PLF
諮詢委員會或
決定相當於

器材摘要

OsteoSinter® EVANS and COTTON wedges and related accessories is the device name listed in this FDA 510(k) record. The listed applicant is Ames Medical Prosthetic Solutions, S.A.U.. It received FDA 510(k) clearance on 2024-12-06 under 510(k) number K240461. 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 OsteoSinter® EVANS and COTTON wedges and related accessories?

OsteoSinter® EVANS and COTTON wedges and related accessories is a medical device that received FDA 510(k) clearance on 2024-12-06. The listed applicant is Ames Medical Prosthetic Solutions, S.A.U.. The 510(k) number is K240461.

When did OsteoSinter® EVANS and COTTON wedges and related accessories receive FDA 510(k) clearance?

OsteoSinter® EVANS and COTTON wedges and related accessories received FDA 510(k) clearance on 2024-12-06, under 510(k) number K240461.

Who is the listed applicant for OsteoSinter® EVANS and COTTON wedges and related accessories?

The FDA 510(k) record lists Ames Medical Prosthetic Solutions, S.A.U. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OsteoSinter® EVANS and COTTON wedges and related accessories?

The FDA product code for OsteoSinter® EVANS and COTTON wedges and related accessories is PLF.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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, LLCK252254骨切楔形系統Sinaptic SurgicalK251791Auxano® 極板固定系統Auxano Medical, LLCK243231三角PEEK HA楔子Nvision Biomedical TechnologiesK234116Trigon Trigon HA 独立楔形固定系統Nvision Biomedical TechnologiesK231496TITAN 3-D 角楔系統Paragon 28, Inc.

官方來源

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