FDA 510(k)

BIOLOX Delta 銀鹹陶瓷股骨頭，BIOLOX Option 銀鹹陶瓷股骨頭系統

K 號：K192416 · 2019-10-01

決定日期2019-10-01

產品代碼LZO

諮詢委員會或

決定相當於

器材摘要

BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer GmbH. It received FDA 510(k) clearance on 2019-10-01 under 510(k) number K192416. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System?

BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System is a medical device that received FDA 510(k) clearance on 2019-10-01. The listed applicant is Zimmer GmbH. The 510(k) number is K192416.

When did BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System receive FDA 510(k) clearance?

BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System received FDA 510(k) clearance on 2019-10-01, under 510(k) number K192416.

Who is the listed applicant for BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System?

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

What is the FDA product code for BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System?

The FDA product code for BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System is LZO.

其他以 Zimmer GmbH 為申請人之記錄

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相關器械（代碼：LZO）

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。

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