510(k) K063551— AEQUALIS HUMERAL PLATE

Substantially Equivalent

Tornier

Clearance details

Applicant: Tornier
Product code: Code KTT
Advisory panel: Orthopedic
Date received: 2006-11-24
Decision date: 2006-12-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Saint-Ismier Cedex, FR

Adverse events under product code KTT

product code KTT

Death: 11
Injury: 3,097
Malfunction: 1,261
Total: 4,369

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.