K243798
- 510(k) number
- K243798
- Device name
- Orthex External Fixation System
- Applicant
- OrthoPediatrics Corp. IN · US
- Product code
- KTT — Appliance, Fixation, Nail/Blade/Plate Combination, M
- Decision date
- 2025-03-07
- Date received
- 2024-12-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K243798.pdf
Official FDA record: K243798
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.