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FDA 510(k)

StealthFix Intraosseous Fixation System

K-Number: K220181 · 2022-03-22

ApplicantNextremity Solutions, Inc.
Decision Date2022-03-22
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

StealthFix Intraosseous Fixation System is a medical device manufactured by Nextremity Solutions, Inc.. It received FDA 510(k) clearance on 2022-03-22 under approval number K220181. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the StealthFix Intraosseous Fixation System?

StealthFix Intraosseous Fixation System is a medical device that received FDA 510(k) clearance on 2022-03-22. It is manufactured by Nextremity Solutions, Inc.. The 510(k) number is K220181.

When was StealthFix Intraosseous Fixation System approved by the FDA?

StealthFix Intraosseous Fixation System received FDA 510(k) clearance on 2022-03-22, under approval number K220181.

What company makes StealthFix Intraosseous Fixation System?

StealthFix Intraosseous Fixation System is manufactured by Nextremity Solutions, Inc..

What is the FDA product code for StealthFix Intraosseous Fixation System?

The FDA product code for StealthFix Intraosseous Fixation System is JDR.

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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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