FDA 510(k)

花骨釘組套

K 號：K170687 · 2017-06-06

決定日期2017-06-06

產品代碼HWC

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決定相當於

器材摘要

Flower Bone Screw Set is the device name listed in this FDA 510(k) record. The listed applicant is Flower Orthopedics Corporation. It received FDA 510(k) clearance on 2017-06-06 under 510(k) number K170687. 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 Flower Bone Screw Set?

Flower Bone Screw Set is a medical device that received FDA 510(k) clearance on 2017-06-06. The listed applicant is Flower Orthopedics Corporation. The 510(k) number is K170687.

When did Flower Bone Screw Set receive FDA 510(k) clearance?

Flower Bone Screw Set received FDA 510(k) clearance on 2017-06-06, under 510(k) number K170687.

Who is the listed applicant for Flower Bone Screw Set?

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

What is the FDA product code for Flower Bone Screw Set?

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

其他以 Flower Orthopedics Corporation 為申請人之記錄

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K192949花縫合釘組

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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官方來源

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