FDA 510(k)

齊默自然指甲系統頭骨脊髓釘

K 號：K192312 · 2019-10-11

決定日期2019-10-11

產品代碼HSB

諮詢委員會或

決定相當於

器材摘要

Zimmer Natural Nail System Cephalomedullary Nails is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer GmbH. It received FDA 510(k) clearance on 2019-10-11 under 510(k) number K192312. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Zimmer Natural Nail System Cephalomedullary Nails?

Zimmer Natural Nail System Cephalomedullary Nails is a medical device that received FDA 510(k) clearance on 2019-10-11. The listed applicant is Zimmer GmbH. The 510(k) number is K192312.

When did Zimmer Natural Nail System Cephalomedullary Nails receive FDA 510(k) clearance?

Zimmer Natural Nail System Cephalomedullary Nails received FDA 510(k) clearance on 2019-10-11, under 510(k) number K192312.

Who is the listed applicant for Zimmer Natural Nail System Cephalomedullary Nails?

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 Zimmer Natural Nail System Cephalomedullary Nails?

The FDA product code for Zimmer Natural Nail System Cephalomedullary Nails is HSB.

其他以 Zimmer GmbH 為申請人之記錄

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K211047CoCr 頭部 K200814Affixus(R) 自然釘(R) 系統上臂釘 K200112齊默髋關節置換設備 K193099解剖肩部系統 K193050Alloclassic Zweymuller SL股骨柄，Alloclassic Zweymuller SL偏心股骨柄 K193030Avenir Muller 植入物，Avenir 粘合固定髋關節植入物

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相關器械（代碼：HSB）

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。

K261345兒童釘針平台髋骨OrthoPediatrics Corp.K261481Pangea 髋骨重建系統Stryker GmbH K253080AND 医療股骨釘系統 (PFNA01); AND 医療股骨釘系統 (PFNA02)Suzhou and Science & Technology Development Corp.K261651Precice™ Max 系統及 Precice™ 腳踝挽救系統NuVasive Specialized Orthopedics K253155富麗金屬可鎖定內骨髓釘系統Beijing Fule Science & Technology Development Co., Ltd.K253046HERA 開合式硬脊釘系統ZheJiang Decans Medical Devices Co., Ltd.

官方來源

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