FDA 510(k)

Asnis® III 穿刺螺釘系統及 Asnis® PRO 穿刺螺釘系統

K 號：K213199 · 2022-01-11

決定日期2022-01-11

產品代碼HWC

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決定相當於

器材摘要

Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker GmbH. It received FDA 510(k) clearance on 2022-01-11 under 510(k) number K213199. 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 Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System?

Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System is a medical device that received FDA 510(k) clearance on 2022-01-11. The listed applicant is Stryker GmbH. The 510(k) number is K213199.

When did Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System receive FDA 510(k) clearance?

Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System received FDA 510(k) clearance on 2022-01-11, under 510(k) number K213199.

Who is the listed applicant for Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System?

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

What is the FDA product code for Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System?

The FDA product code for Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System is HWC. This falls under the Cardiovascular category.