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FDA 510(k)

iTotal® 身份™ 閃綁保留 3DP 多孔膝關節置換系統

K 號：K243768 · 2025-03-27

申請人Restor3D, Inc.
決定日期2025-03-27
產品代碼MBH
諮詢委員會或
決定相當於

器材摘要

iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System is the device name listed in this FDA 510(k) record. The listed applicant is Restor3D, Inc.. It received FDA 510(k) clearance on 2025-03-27 under 510(k) number K243768. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System?

iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System is a medical device that received FDA 510(k) clearance on 2025-03-27. The listed applicant is Restor3D, Inc.. The 510(k) number is K243768.

When did iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System receive FDA 510(k) clearance?

iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System received FDA 510(k) clearance on 2025-03-27, under 510(k) number K243768.

Who is the listed applicant for iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System?

The FDA 510(k) record lists Restor3D, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System?

The FDA product code for iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System is MBH.

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 Restor3D, 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。

K252067維羅拉骨盂系統K242356潮汐融合籠架系統K240591restor3d 騰博 Axiom 全踝系統K201393restor3d MTP植入體K201314Restor3d 用具楔板

相關器械（代碼：MBH）

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。

K261275Unity全膝系統，Unity膝水泥無縫股骨Corin, Ltd.K261462LANDMARK 全膝系統Smith & Nephew, Inc.K253728EVOLUTION® AM BIOFOAM® 道骨系統Microport Orthopedics, Inc.K251840齊默® 佩森娜® 適合個人化膝關節系統Zimmer, Inc.K253189Persona 個人化膝關節系統（Persona 多孔等离子喷涂 PPS 髋骨）Zimmer, Inc.K253328GMK 3D金屬胫骨托延伸器Medacta International S.A.

官方來源

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