510(k) K192745— DePuy Synthes Trauma Screws

Substantially Equivalent

Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.

Clearance details

Applicant: Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2019-09-30
Decision date: 2019-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, US

Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.