FDA 510(k)

物理多孔股骨组件

K 號：K243615 · 2024-12-18

決定日期2024-12-18

產品代碼MBH

諮詢委員會或

決定相當於

器材摘要

Physica Porous Femoral Components is the device name listed in this FDA 510(k) record. The listed applicant is Lima Corporate S.P.A.. It received FDA 510(k) clearance on 2024-12-18 under 510(k) number K243615. 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 Physica Porous Femoral Components?

Physica Porous Femoral Components is a medical device that received FDA 510(k) clearance on 2024-12-18. The listed applicant is Lima Corporate S.P.A.. The 510(k) number is K243615.

When did Physica Porous Femoral Components receive FDA 510(k) clearance?

Physica Porous Femoral Components received FDA 510(k) clearance on 2024-12-18, under 510(k) number K243615.

Who is the listed applicant for Physica Porous Femoral Components?

The FDA 510(k) record lists Lima Corporate S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Physica Porous Femoral Components?

The FDA product code for Physica Porous Femoral Components is MBH.

其他以 Lima Corporate S.P.A. 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。

K252352SMR肩關節系統；PRIMA關節盂系統；PRIMA肱骨系統 K251718ArTT 增強與支撐及骨釘 K243826SMR逆向高壓肩關節系統 K250980Physica 系統（Physica CR 多孔股骨组件）K234011AMF TT Cones K233712PRIMA 肱骨系統；PRIMA TT 閃輪

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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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