Tahoe Unicondylar Knee System with TiNbN Overcoat— 510(k) K260796
Substantially EquivalentShalby Advanced Technologies, Inc. Dba Consensus Orthopedics
FDA 510(k) clearance K260796 for Tahoe Unicondylar Knee System with TiNbN Overcoat, Substantially Equivalent on 2026-04-02. Applicant: Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics.
Clearance details
- Applicant
- Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics
- Product code
- Code HSX
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- El Dorado Hills, CA, US
Adverse events under product code HSX
product code HSX- Injury
- 1,003
- Other
- 1
- Total
- 1,004
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.