K242711
- 510(k) number
- K242711
- Device name
- JOURNEY II Unicompartmental Knee System (JOURNEY II UK)
- Applicant
- Smith & Nephew, Inc. TN · US
- Product code
- HSX — Prosthesis, Knee, Femorotibial, Non-Constrained, Cem
- Decision date
- 2024-10-30
- Date received
- 2024-09-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K242711.pdf
Official FDA record: K242711
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.