510(k) K952928— AEQUALIS SHOULDER SYSTEM FOR TOTAL & HEMISHOULDER APPLICATIONS

Substantially Equivalent

Tornier

Clearance details

Applicant: Tornier
Product code: Code KWS
Advisory panel: Orthopedic
Date received: 1995-06-26
Decision date: 1995-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, US

Adverse events under product code KWS

product code KWS

Death: 6
Injury: 9,652
Malfunction: 1,385
Other: 1
Total: 11,044

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.