K230088
- 510(k) number
- K230088
- Device name
- Ankle Truss System (ATS)
- Applicant
- 4Web Medical, Inc. TX · US
- Product code
- SAI — Ankle Fusion Cage
- Decision date
- 2024-03-21
- Date received
- 2023-01-12
- 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: K230088.pdf
Official FDA record: K230088
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.