FDA 510(k)

骨醫療 PINNACLE 驅動器

K 號：K162542 · 2017-05-19

決定日期2017-05-19

產品代碼HBE

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

OsteoMed PINNACLE Driver is the device name listed in this FDA 510(k) record. The listed applicant is Osteomed. It received FDA 510(k) clearance on 2017-05-19 under 510(k) number K162542. The device is classified under product code HBE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OsteoMed PINNACLE Driver?

OsteoMed PINNACLE Driver is a medical device that received FDA 510(k) clearance on 2017-05-19. The listed applicant is Osteomed. The 510(k) number is K162542.

When did OsteoMed PINNACLE Driver receive FDA 510(k) clearance?

OsteoMed PINNACLE Driver received FDA 510(k) clearance on 2017-05-19, under 510(k) number K162542.

Who is the listed applicant for OsteoMed PINNACLE Driver?

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

What is the FDA product code for OsteoMed PINNACLE Driver?

The FDA product code for OsteoMed PINNACLE Driver is HBE.

其他以 Osteomed 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。

K203479ExtremiLOCK 外翻踝關節融合板 K162544骨醫療 PINNACLE 驅動器 K161041OsteoMed ExtremiLOCK 腕骨板系統

相關器械（代碼：HBE）

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。

官方來源

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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。