InSet Total Shoulder System— 510(k) K241817
Substantially EquivalentShoulder Innovations, Inc.
FDA 510(k) clearance K241817 for InSet Total Shoulder System, Substantially Equivalent on 2025-02-11. Applicant: Shoulder Innovations, Inc..
Clearance details
- Applicant
- Shoulder Innovations, Inc.
- Product code
- Code KWT
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Grand Rapids, MI, US
Adverse events under product code KWT
product code KWT- Injury
- 2,467
- Other
- 2
- Total
- 2,469
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.