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FDA 510(k)

StealthFix Intraosseous Fixation System

K-Number: K232324 · 2023-08-30

ApplicantMedartis, Inc.
Decision Date2023-08-30
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

StealthFix Intraosseous Fixation System is a medical device manufactured by Medartis, Inc.. It received FDA 510(k) clearance on 2023-08-30 under approval number K232324. 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 2023-08-30. It is manufactured by Medartis, Inc.. The 510(k) number is K232324.

When was StealthFix Intraosseous Fixation System approved by the FDA?

StealthFix Intraosseous Fixation System received FDA 510(k) clearance on 2023-08-30, under approval number K232324.

What company makes StealthFix Intraosseous Fixation System?

StealthFix Intraosseous Fixation System is manufactured by Medartis, Inc..

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

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

Related Clinical Trials

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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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