K230067
- 510(k) number
- K230067
- Device name
- Para-Fix External Fixation System
- Applicant
- New Paradigm Biomedical MA · US
- Product code
- LXT — Appliance, Fixation, Nail/Blade/Plate Combination, M
- Decision date
- 2023-09-22
- Date received
- 2023-01-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.3 MB · U.S. public domain
Also available from FDA: K230067.pdf
Official FDA record: K230067
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.