FDA 510(k)

OVOMotion 頸關節翻轉人工關節系統

K 號：K203375 · 2021-06-24

決定日期2021-06-24

產品代碼PHX

諮詢委員會或

決定相當於

器材摘要

OVOMotion Reverse Shoulder 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 2021-06-24 under 510(k) number K203375. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OVOMotion Reverse Shoulder Arthroplasty System?

OVOMotion Reverse Shoulder Arthroplasty System is a medical device that received FDA 510(k) clearance on 2021-06-24. The listed applicant is Arthrosurface, Inc.. The 510(k) number is K203375.

When did OVOMotion Reverse Shoulder Arthroplasty System receive FDA 510(k) clearance?

OVOMotion Reverse Shoulder Arthroplasty System received FDA 510(k) clearance on 2021-06-24, under 510(k) number K203375.

Who is the listed applicant for OVOMotion Reverse Shoulder 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 OVOMotion Reverse Shoulder Arthroplasty System?

The FDA product code for OVOMotion Reverse Shoulder Arthroplasty System is PHX.

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。

K200718Arthrosurface WristMotion 總腕關節置换系統 K190261BOSS腳趾固定系統 K181280膝蓋-股骨波（Kahuna）關節成形系統 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：PHX）

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。

K260556Veritas肩部系統Restor3D K261683Augment 偏心儀器系統Zimmer, Inc.K260102Tornier Perform Reversed Glenoid和Tornier Perform Reversed Augmented Glenoid Shoulder System的設備名稱Stryker Corporation (Tornier, Inc.)K261016MSS - 肱骨反覆蓋擴充件Medacta International, SA K253992Veritas逆向全肩關節系統Restor3D K252404全面反向肩蓋 - HA 髖關節基板Biomet Orthopedics

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