FDA 510(k)

膝蓋-股骨波（Kahuna）關節成形系統

K 號：K181280 · 2018-06-14

決定日期2018-06-14

產品代碼KRR

諮詢委員會或

決定相當於

器材摘要

Patello-Femoral Wave (Kahuna) Arthroplasty System is the device name listed in this FDA 510(k) record. The listed applicant is Arthrosurface, Inc.. It received FDA 510(k) clearance on 2018-06-14 under 510(k) number K181280. 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 Patello-Femoral Wave (Kahuna) Arthroplasty System?

Patello-Femoral Wave (Kahuna) Arthroplasty System is a medical device that received FDA 510(k) clearance on 2018-06-14. The listed applicant is Arthrosurface, Inc.. The 510(k) number is K181280.

When did Patello-Femoral Wave (Kahuna) Arthroplasty System receive FDA 510(k) clearance?

Patello-Femoral Wave (Kahuna) Arthroplasty System received FDA 510(k) clearance on 2018-06-14, under 510(k) number K181280.

Who is the listed applicant for Patello-Femoral Wave (Kahuna) Arthroplasty System?

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

What is the FDA product code for Patello-Femoral Wave (Kahuna) Arthroplasty System?

The FDA product code for Patello-Femoral Wave (Kahuna) Arthroplasty System is KRR.

其他以 Arthrosurface, 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。

K203375OVOMotion 頸關節翻轉人工關節系統 K200718Arthrosurface WristMotion 總腕關節置换系統 K190261BOSS腳趾固定系統 K173964OVOMotion 肩關節置換系統 K172383Arthrosurface 骨螺釘 K170440KISSloc 緝合系統

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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.K221048Episealer 髌股系統Episurf Medical, Inc.K211303Avon 髌股關節置換器Howmedica Osteonics Corp., Dba Stryker Orthopaedics K200122MOTO PFJ 系統Medacta International S.A.K160461Arthrex iBalance 兩間室人工關節置换系統Arthrex, Inc.

官方來源

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