LATITUDE EV Total Elbow Arthroplasty— 510(k) K182461

Substantially Equivalent

Tornier, Inc.

FDA 510(k) clearance K182461 for LATITUDE EV Total Elbow Arthroplasty, Substantially Equivalent on 2018-12-27. Applicant: Tornier, Inc..

Clearance details

Applicant: Tornier, Inc.
Product code: Code JDB
Advisory panel: Orthopedic
Date received: 2018-09-10
Decision date: 2018-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, MN, US

Download summary PDF View on FDA.gov ↗

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.