FDA 510(k)

ARROW 反向多孔盂

K 號：K171789 · 2018-01-23

決定日期2018-01-23

產品代碼PHX

諮詢委員會或

決定相當於

器材摘要

ARROW Reverse Porous Glenoid is the device name listed in this FDA 510(k) record. The listed applicant is Fournitures Hospitalieres Industrie. It received FDA 510(k) clearance on 2018-01-23 under 510(k) number K171789. 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 ARROW Reverse Porous Glenoid?

ARROW Reverse Porous Glenoid is a medical device that received FDA 510(k) clearance on 2018-01-23. The listed applicant is Fournitures Hospitalieres Industrie. The 510(k) number is K171789.

When did ARROW Reverse Porous Glenoid receive FDA 510(k) clearance?

ARROW Reverse Porous Glenoid received FDA 510(k) clearance on 2018-01-23, under 510(k) number K171789.

Who is the listed applicant for ARROW Reverse Porous Glenoid?

The FDA 510(k) record lists Fournitures Hospitalieres Industrie as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARROW Reverse Porous Glenoid?

The FDA product code for ARROW Reverse Porous Glenoid is PHX.

其他以 Fournitures Hospitalieres Industrie 為申請人之記錄

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K163148BePOD® 腳螺釘 K163710BePOD® EZ Weil 钉子 K162068ARROW 解剖多孔盂 K170040BePOD 穿刺關節融合螺釘

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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