K223421
- 510(k) number
- K223421
- Device name
- MedCAD AccuPlan Orthopedics System
- Applicant
- Medcad TX · US
- Product code
- PBF — Orthopaedic Surgical Planning And Instrument Guides
- Decision date
- 2023-09-20
- Date received
- 2022-11-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K223421.pdf
Official FDA record: K223421
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.