Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is New Paradigm Biomedical. It received FDA 510(k) clearance on 2023-09-22 under 510(k) 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. The listed applicant is New Paradigm Biomedical. The 510(k) number is K230067.

When did Para-Fix External Fixation System receive FDA 510(k) clearance?

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

Who is the listed applicant for Para-Fix External Fixation System?

The FDA 510(k) record lists New Paradigm Biomedical as the applicant. This does not by itself establish the device manufacturer.

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

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

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.

↑