K193247

Substantially Equivalent

LATITUDE EV Total Elbow Arthroplasty

Applicant: Tornier, Inc.
Product code: JDB
Advisory panel: Orthopedic
Date received: 2019-11-25
Decision date: 2020-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, MN, US

Adverse events under product code JDB

product code JDB

Injury: 352
Total: 352

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.