Shoulder Innovations Total Shoulder System— 510(k) K192365

Substantially Equivalent

Shoulder Innovations, Inc.

FDA 510(k) clearance K192365 for Shoulder Innovations Total Shoulder System, Substantially Equivalent on 2019-11-29. Applicant: Shoulder Innovations, Inc..

Clearance details

Applicant: Shoulder Innovations, Inc.
Product code: Code KWT
Advisory panel: Orthopedic
Date received: 2019-08-30
Decision date: 2019-11-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Holland, 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, 2020-01-01 through 2026-04-23. 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.