OvertureTi Knee Resurfacing SystemTM— 510(k) K242746
Substantially EquivalentOverture Orthopaedics
FDA 510(k) clearance K242746 for OvertureTi Knee Resurfacing SystemTM, Substantially Equivalent on 2024-10-07. Applicant: Overture Orthopaedics.
Clearance details
- Applicant
- Overture Orthopaedics
- Product code
- Code HSX
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Irvine, 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.