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FDA 510(k)

Para-Fix External Fixation System

K-Number: K230067 · 2023-09-22

ApplicantNew Paradigm Biomedical
Decision Date2023-09-22
Product CodeLXT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Para-Fix External Fixation System is a medical device manufactured by New Paradigm Biomedical. It received FDA 510(k) clearance on 2023-09-22 under approval number K230067. The device is classified under product code LXT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Para-Fix External Fixation System?

Para-Fix External Fixation System is a medical device that received FDA 510(k) clearance on 2023-09-22. It is manufactured by New Paradigm Biomedical. The 510(k) number is K230067.

When was Para-Fix External Fixation System approved by the FDA?

Para-Fix External Fixation System received FDA 510(k) clearance on 2023-09-22, under approval number K230067.

What company makes Para-Fix External Fixation System?

Para-Fix External Fixation System is manufactured by New Paradigm Biomedical.

What is the FDA product code for Para-Fix External Fixation System?

The FDA product code for Para-Fix External Fixation System is LXT.

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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