FDA 510(k)

ARROW 解剖多孔盂

K 號：K162068 · 2017-04-10

決定日期2017-04-10

產品代碼MBF

諮詢委員會或

決定相當於

器材摘要

ARROW Anatomical 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 2017-04-10 under 510(k) number K162068. The device is classified under product code MBF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ARROW Anatomical Porous glenoid?

ARROW Anatomical Porous glenoid is a medical device that received FDA 510(k) clearance on 2017-04-10. The listed applicant is Fournitures Hospitalieres Industrie. The 510(k) number is K162068.

When did ARROW Anatomical Porous glenoid receive FDA 510(k) clearance?

ARROW Anatomical Porous glenoid received FDA 510(k) clearance on 2017-04-10, under 510(k) number K162068.

Who is the listed applicant for ARROW Anatomical 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 Anatomical Porous glenoid?

The FDA product code for ARROW Anatomical Porous glenoid is MBF.

其他以 Fournitures Hospitalieres Industrie 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。

K171789ARROW 反向多孔盂 K163148BePOD® 腳螺釘 K163710BePOD® EZ Weil 钉子 K170040BePOD 穿刺關節融合螺釘

相關器械（代碼：MBF）

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。

K253592Zimmer Biomet 反向肩蓋假體（Alliance 肱骨承重環，Identity 肱骨托盤，全面性反向肱骨托盤，全面性反向 32mm 髋球和適配器）Zimmer, Inc.K251098身份修復上臂干Zimmer, Inc.K250848身份肩部系統Zimmer, Inc.K240876身份肩部系統Zimmer, Inc.K233712PRIMA 肱骨系統；PRIMA TT 閃輪Lima Corporate S.P.A.K231099SMR雙模擬盂蓋系統Lima Corporate S.P.A.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。