K230398
- 510(k) number
- K230398
- Device name
- MedCAD® AccuPlate® 3DTi Patient-Specific Plating System
- Applicant
- Medcad TX · US
- Product code
- JEY — Plate, Bone
- Decision date
- 2023-09-26
- Date received
- 2023-02-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K230398.pdf
Official FDA record: K230398
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.