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FDA 510(k)

Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System

K-Number: K213199 · 2022-01-11

ApplicantStryker GmbH
Decision Date2022-01-11
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System is a medical device manufactured by Stryker GmbH. It received FDA 510(k) clearance on 2022-01-11 under approval 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.

Frequently Asked Questions

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. It is manufactured by Stryker GmbH. The 510(k) number is K213199.

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

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

What company makes Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System?

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

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.

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Official Source

View on FDA Database →

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

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