FDA 510(k)

Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System

K-Number: K220319 · 2022-06-10

Decision Date2022-06-10

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System is a medical device manufactured by Stryker GmbH. It received FDA 510(k) clearance on 2022-06-10 under approval number K220319. 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.

Frequently Asked Questions

What is the Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System?

Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System is a medical device that received FDA 510(k) clearance on 2022-06-10. It is manufactured by Stryker GmbH. The 510(k) number is K220319.

When was Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System approved by the FDA?

Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System received FDA 510(k) clearance on 2022-06-10, under approval number K220319.

What company makes Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System?

Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System is manufactured by Stryker GmbH.

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

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

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Related PubMed Literature

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.