DeviceClearance

K241817

Substantially Equivalent

InSet Total Shoulder System

Applicant
Shoulder Innovations, Inc.
Product code
KWT
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Grand Rapids, MI, US
Download summary PDF View on FDA.gov ↗

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.