FDA 510(k)

Syntec 道骨釘系統

K 號：K191617 · 2019-09-03

決定日期2019-09-03

產品代碼HSB

諮詢委員會或

決定相當於

器材摘要

Syntec Tibial Nail System is the device name listed in this FDA 510(k) record. The listed applicant is Syntec Scientific Corporation. It received FDA 510(k) clearance on 2019-09-03 under 510(k) number K191617. 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 Syntec Tibial Nail System?

Syntec Tibial Nail System is a medical device that received FDA 510(k) clearance on 2019-09-03. The listed applicant is Syntec Scientific Corporation. The 510(k) number is K191617.

When did Syntec Tibial Nail System receive FDA 510(k) clearance?

Syntec Tibial Nail System received FDA 510(k) clearance on 2019-09-03, under 510(k) number K191617.

Who is the listed applicant for Syntec Tibial Nail System?

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

What is the FDA product code for Syntec Tibial Nail System?

The FDA product code for Syntec Tibial Nail System is HSB.

其他以 Syntec Scientific Corporation 為申請人之記錄

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K202790矯正醫療設備規範文本翻譯：矯正醫療設備迷你螺釘延長系統 K202935Syntec 髋骨釘擴充系統 K200933Syntec 非无菌史坦曼釘系統 K181296Syntec 髋部釘系統 K161327SynTEC 肱骨釘系統

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.

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