FDA 510(k)

ATLAS™ Expandable Osteotomy Wedge System

K 號：K252733 · 2026-02-19

決定日期2026-02-19

產品代碼PLF

諮詢委員會或

決定相當於

器材摘要

ATLAS™ Expandable Osteotomy Wedge System is the device name listed in this FDA 510(k) record. The listed applicant is MiRus, LLC. It received FDA 510(k) clearance on 2026-02-19 under 510(k) number K252733. 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 ATLAS™ Expandable Osteotomy Wedge System?

ATLAS™ Expandable Osteotomy Wedge System is a medical device that received FDA 510(k) clearance on 2026-02-19. The listed applicant is MiRus, LLC. The 510(k) number is K252733.

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

ATLAS™ Expandable Osteotomy Wedge System received FDA 510(k) clearance on 2026-02-19, under 510(k) number K252733.

Who is the listed applicant for ATLAS™ Expandable Osteotomy Wedge System?

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

What is the FDA product code for ATLAS™ Expandable Osteotomy Wedge System?

The FDA product code for ATLAS™ Expandable Osteotomy Wedge System is PLF.

其他以 MiRus, 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。

K253444EUROPA™ 頸椎後融合導航儀器 K242516EUROPA™ 頸椎後融合系統 K241175MiRus MoRe 腰椎板系統 K232348RIGEL™ 3DR 独立式前方颈椎椎間融合系統 K232481RIGEL™ 3DR 頸部前方椎體切除系統 K232154MiRus 3DR 腰椎間融合系統，配備整合式板塊固定

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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。

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 K231496TITAN 3-D 角楔系統Paragon 28, Inc.

官方來源

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