510(k) K113760— VARIAX SUPERIOR AND ANTERIOR, LATERAL AND MIDSHAFT CLAVICLE PLATES VARIAX AIMING BLOCKS & JOYSTICK

Substantially Equivalent

Howmedica Osteonics Corp., Dba Stryker Orthopaedics

Clearance details

Applicant: Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2011-12-21
Decision date: 2012-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mahwah, NJ, US

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.