Para-Fix External Fixation System— 510(k) K230067

Name: FDA 510(k) clearance K230067
Creator: U.S. Food and Drug Administration
Published: 2023-09-22

Substantially Equivalent

New Paradigm Biomedical

FDA 510(k) clearance K230067 for Para-Fix External Fixation System, Substantially Equivalent on 2023-09-22. Applicant: New Paradigm Biomedical. Device class: 2.

Clearance details

Applicant: New Paradigm Biomedical
Product code: Code LXT
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2023-01-09
Decision date: 2023-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Needham, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.