K260796
- 510(k) number
- K260796
- Device name
- Tahoe Unicondylar Knee System with TiNbN Overcoat
- Applicant
- Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics CA · US
- Product code
- HSX — Prosthesis, Knee, Femorotibial, Non-Constrained, Cem
- Decision date
- 2026-04-02
- Date received
- 2026-03-11
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K260796.pdf
Official FDA record: K260796
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.