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FDA 510(k)

骨心臟前交叉韁綁固定系統

K 號：K230595 · 2023-06-29

申請人OsteoCentric Technologies
決定日期2023-06-29
產品代碼HWC
諮詢委員會或
決定相當於

器材摘要

OsteoCentric ACL Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is OsteoCentric Technologies. It received FDA 510(k) clearance on 2023-06-29 under 510(k) number K230595. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the OsteoCentric ACL Fixation System?

OsteoCentric ACL Fixation System is a medical device that received FDA 510(k) clearance on 2023-06-29. The listed applicant is OsteoCentric Technologies. The 510(k) number is K230595.

When did OsteoCentric ACL Fixation System receive FDA 510(k) clearance?

OsteoCentric ACL Fixation System received FDA 510(k) clearance on 2023-06-29, under 510(k) number K230595.

Who is the listed applicant for OsteoCentric ACL Fixation System?

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

What is the FDA product code for OsteoCentric ACL Fixation System?

The FDA product code for OsteoCentric ACL Fixation System is HWC. This falls under the Cardiovascular category.

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

其他以 OsteoCentric Technologies 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。

K251913OsteoCentric® UnifiMI® TCS 鋼板系統K250494OsteoCentric 骨板及螺釘系統K242691OsteoCentric Technologies 穿刺螺釘及螺母K230242骨心齒植體系統K230226Integrity-SI® 結合系統K230764骨心整合髋關節固定系統

查看所有 11 項裝置 →

相關器械（代碼：HWC）

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。

K262975Arthrex Beaming系統Arthrex, Inc.K260995DynaNail螺旋®固定系統MedShape, Inc.K254280F.A.S.T. 螺釘Steps OrthoK261057ActivaScrew™ 穿刺式 COMBioretec, Ltd.K260106OsteoCoil™ GT 活動壓縮系統Flower Orthopedics Corporation DBA Conventus Flower OrthopedK262344大型壓縮螺釘TriMed, Inc.

官方來源

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