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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 the device name listed in this FDA 510(k) record. The listed applicant is Medartis, Inc.. It received FDA 510(k) clearance on 2023-08-30 under 510(k) 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. The listed applicant is Medartis, Inc.. The 510(k) number is K232324.

When did StealthFix Intraosseous Fixation System receive FDA 510(k) clearance?

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

Who is the listed applicant for StealthFix Intraosseous Fixation System?

The FDA 510(k) record lists Medartis, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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