FDA 510(k)

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K 號：K153338 · 2016-01-14

決定日期2016-01-14

產品代碼HWC

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器材摘要

Tiger Cannulated Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Trilliant Surgical, Ltd.. It received FDA 510(k) clearance on 2016-01-14 under 510(k) number K153338. 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 Tiger Cannulated Screw System?

Tiger Cannulated Screw System is a medical device that received FDA 510(k) clearance on 2016-01-14. The listed applicant is Trilliant Surgical, Ltd.. The 510(k) number is K153338.

When did Tiger Cannulated Screw System receive FDA 510(k) clearance?

Tiger Cannulated Screw System received FDA 510(k) clearance on 2016-01-14, under 510(k) number K153338.

Who is the listed applicant for Tiger Cannulated Screw System?

The FDA 510(k) record lists Trilliant Surgical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tiger Cannulated Screw System?

The FDA product code for Tiger Cannulated Screw System is HWC. This falls under the Cardiovascular category.

其他以 Trilliant Surgical, Ltd. 為申請人之記錄

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