FDA 510(k)

骨釘線增補

K 號：K191289 · 2019-07-29

決定日期2019-07-29

產品代碼HWC

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器材摘要

Bone Screw Line Addition is the device name listed in this FDA 510(k) record. The listed applicant is Vilex IN Tennessee, Inc.. It received FDA 510(k) clearance on 2019-07-29 under 510(k) number K191289. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the Bone Screw Line Addition?

Bone Screw Line Addition is a medical device that received FDA 510(k) clearance on 2019-07-29. The listed applicant is Vilex IN Tennessee, Inc.. The 510(k) number is K191289.

When did Bone Screw Line Addition receive FDA 510(k) clearance?

Bone Screw Line Addition received FDA 510(k) clearance on 2019-07-29, under 510(k) number K191289.

Who is the listed applicant for Bone Screw Line Addition?

The FDA 510(k) record lists Vilex IN Tennessee, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bone Screw Line Addition?

The FDA product code for Bone Screw Line Addition is HWC. This falls under the Cardiovascular category.

其他以 Vilex IN Tennessee, Inc. 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。

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相關器械（代碼：HWC）

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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