FDA 510(k)

Platform® 髋臼系統

K 號：K220483 · 2022-09-23

決定日期2022-09-23

產品代碼LZO

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決定相當於

器材摘要

Platform® Acetabular System is the device name listed in this FDA 510(k) record. The listed applicant is Total Joint Orthopedics, Inc.. It received FDA 510(k) clearance on 2022-09-23 under 510(k) number K220483. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Platform® Acetabular System?

Platform® Acetabular System is a medical device that received FDA 510(k) clearance on 2022-09-23. The listed applicant is Total Joint Orthopedics, Inc.. The 510(k) number is K220483.

When did Platform® Acetabular System receive FDA 510(k) clearance?

Platform® Acetabular System received FDA 510(k) clearance on 2022-09-23, under 510(k) number K220483.

Who is the listed applicant for Platform® Acetabular System?

FDA 510(k) 記錄將 Total Joint Orthopedics, Inc. 列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Platform® Acetabular System?

The FDA product code for Platform® Acetabular System is LZO.

其他以 Total Joint Orthopedics, 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。

K261734Klassic感染間隔系統 K211877Klassic 適合膝關節系統 K211602Klassic 適合膝關節系統 K202740Klassic膝關節系統胫骨插板，PS-Max K183596Klassic膝關節系統 - Klassic膝關節 PS-Post大腿；Klassic膝關節胫骨植入體，PS-Post，標準多聚物；Klassic膝關節胫骨植入體，PS-Post，E-Link多聚物 K190280Klassic 適合膝關節系統 - Sombrero 適合膝蓋標準多聚物，Klassic 適合膝關節系統 - Sombrero 適合膝蓋 E-Link 多聚物

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相關器械（代碼：LZO）

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。

K260173M-Vizion 髋關節更換系統擴充版Medacta International S.A.K253948動力骨盂杯系統United Orthopedic Corporation K261009MobileLink 骨盆杯系統 – 40mm ID 插片（各種）Waldemar Link GmbH & Co. KG K260831Z1 髋關節系統Zimmer, Inc.K260182Avenir® Müller 植入物；Avenir Complete™ 髋關節系統Zimmer, Inc.K260037植入式醫療設備包裝系統更新Implantcast GmbH

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