K243174
- 510(k) number
- K243174
- Device name
- Cadence Ankle PSI System
- Applicant
- 3D Systems, Inc. CO · US
- Product code
- OYK — Ankle Arthroplasty Implantation System
- Decision date
- 2024-10-25
- Date received
- 2024-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K243174.pdf
Official FDA record: K243174
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.