FDA 510(k)

INnate Cannulated Screw System

K-Number: K183603 · 2019-03-12

Decision Date2019-03-12

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

INnate Cannulated Screw System is a medical device manufactured by Exsomed Corporation. It received FDA 510(k) clearance on 2019-03-12 under approval number K183603. 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 INnate Cannulated Screw System?

INnate Cannulated Screw System is a medical device that received FDA 510(k) clearance on 2019-03-12. It is manufactured by Exsomed Corporation. The 510(k) number is K183603.

When was INnate Cannulated Screw System approved by the FDA?

INnate Cannulated Screw System received FDA 510(k) clearance on 2019-03-12, under approval number K183603.

What company makes INnate Cannulated Screw System?

INnate Cannulated Screw System is manufactured by Exsomed Corporation.

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

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

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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.