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FDA 510(k)

骨切楔形系統

K 號：K252254 · 2025-10-17

申請人Sinaptic Surgical
決定日期2025-10-17
產品代碼PLF
諮詢委員會或
決定相當於

器材摘要

Osteotomy Wedge System is the device name listed in this FDA 510(k) record. The listed applicant is Sinaptic Surgical. It received FDA 510(k) clearance on 2025-10-17 under 510(k) number K252254. 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 Osteotomy Wedge System?

Osteotomy Wedge System is a medical device that received FDA 510(k) clearance on 2025-10-17. The listed applicant is Sinaptic Surgical. The 510(k) number is K252254.

When did Osteotomy Wedge System receive FDA 510(k) clearance?

Osteotomy Wedge System received FDA 510(k) clearance on 2025-10-17, under 510(k) number K252254.

Who is the listed applicant for Osteotomy Wedge System?

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

What is the FDA product code for Osteotomy Wedge System?

The FDA product code for Osteotomy Wedge System 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, LLCK251791Auxano® 極板固定系統Auxano Medical, LLCK240461OsteoSinter® 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 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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