K221787
- 510(k) number
- K221787
- Device name
- Auxein's DHS/DCS Plate System
- Applicant
- Auxein Medical Private Limited IN
- Product code
- KTT — Appliance, Fixation, Nail/Blade/Plate Combination, M
- Decision date
- 2023-11-30
- Date received
- 2022-06-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K221787.pdf
Official FDA record: K221787
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.