K241148
- 510(k) number
- K241148
- Device name
- Salto Talaris Ankle PSI System
- Applicant
- 3D Systems, Inc. CO · US
- Product code
- OYK — Ankle Arthroplasty Implantation System
- Decision date
- 2024-08-30
- Date received
- 2024-04-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K241148.pdf
Official FDA record: K241148
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.