FDA 510(k)

ExsoMed INnate NanoTM Lag Screw System

K-Number: K220892 · 2022-04-27

Decision Date2022-04-27

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

ExsoMed INnate NanoTM Lag Screw System is a medical device manufactured by Exsomed Corp.. It received FDA 510(k) clearance on 2022-04-27 under approval number K220892. 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 ExsoMed INnate NanoTM Lag Screw System?

ExsoMed INnate NanoTM Lag Screw System is a medical device that received FDA 510(k) clearance on 2022-04-27. It is manufactured by Exsomed Corp.. The 510(k) number is K220892.

When was ExsoMed INnate NanoTM Lag Screw System approved by the FDA?

ExsoMed INnate NanoTM Lag Screw System received FDA 510(k) clearance on 2022-04-27, under approval number K220892.

What company makes ExsoMed INnate NanoTM Lag Screw System?

ExsoMed INnate NanoTM Lag Screw System is manufactured by Exsomed Corp..

What is the FDA product code for ExsoMed INnate NanoTM Lag Screw System?

The FDA product code for ExsoMed INnate NanoTM Lag 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.