FDA 510(k)

Taperloc® 完整股骨柄

K 號：K200196 · 2020-12-08

決定日期2020-12-08

產品代碼LZO

諮詢委員會或

決定相當於

器材摘要

Taperloc® Complete Hip Stems is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Orthopedics. It received FDA 510(k) clearance on 2020-12-08 under 510(k) number K200196. 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 Taperloc® Complete Hip Stems?

Taperloc® Complete Hip Stems is a medical device that received FDA 510(k) clearance on 2020-12-08. The listed applicant is Biomet Orthopedics. The 510(k) number is K200196.

When did Taperloc® Complete Hip Stems receive FDA 510(k) clearance?

Taperloc® Complete Hip Stems received FDA 510(k) clearance on 2020-12-08, under 510(k) number K200196.

Who is the listed applicant for Taperloc® Complete Hip Stems?

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

What is the FDA product code for Taperloc® Complete Hip Stems?

The FDA product code for Taperloc® Complete Hip Stems is LZO.

其他以 Biomet Orthopedics 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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