K231887
- 510(k) number
- K231887
- Device name
- ARIX Ankle Distal Tibia System
- Applicant
- Jeil Medical Corporation KR
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2023-12-14
- Date received
- 2023-06-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K231887.pdf
Official FDA record: K231887
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.