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FDA 510(k)

Episealer 髌股系統

K 號：K221048 · 2022-12-23

申請人Episurf Medical, Inc.
決定日期2022-12-23
產品代碼KRR
諮詢委員會或
決定相當於

器材摘要

Episealer Patellofemoral System is the device name listed in this FDA 510(k) record. The listed applicant is Episurf Medical, Inc.. It received FDA 510(k) clearance on 2022-12-23 under 510(k) number K221048. The device is classified under product code KRR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Episealer Patellofemoral System?

Episealer Patellofemoral System is a medical device that received FDA 510(k) clearance on 2022-12-23. The listed applicant is Episurf Medical, Inc.. The 510(k) number is K221048.

When did Episealer Patellofemoral System receive FDA 510(k) clearance?

Episealer Patellofemoral System received FDA 510(k) clearance on 2022-12-23, under 510(k) number K221048.

Who is the listed applicant for Episealer Patellofemoral System?

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

What is the FDA product code for Episealer Patellofemoral System?

The FDA product code for Episealer Patellofemoral System is KRR.

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

相關器械（代碼：KRR）

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。

K231253Overture骨科髌股系統Overture Resurfacing, Inc.K211303Avon 髌股關節置換器Howmedica Osteonics Corp., Dba Stryker OrthopaedicsK200122MOTO PFJ 系統Medacta International S.A.K181280膝蓋-股骨波（Kahuna）關節成形系統Arthrosurface, Inc.K160461Arthrex iBalance 兩間室人工關節置换系統Arthrex, Inc.

官方來源

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