K250472
- 510(k) number
- K250472
- Device name
- SixFix Hexapod Fixator and Deformity Analysis and Correction Software (DACS)
- Applicant
- Amdt Holdings, Inc. TN · US
- Product code
- KTT — Appliance, Fixation, Nail/Blade/Plate Combination, M
- Decision date
- 2025-08-08
- Date received
- 2025-02-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K250472.pdf
Official FDA record: K250472
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.