510(k) K191271— T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System

Substantially Equivalent

Stryker Trauma GmbH

Clearance details

Applicant: Stryker Trauma GmbH
Product code: Code HSB
Advisory panel: Orthopedic
Date received: 2019-05-13
Decision date: 2019-06-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Schoenkirchen, DE

Adverse events under product code HSB

product code HSB

Death: 49
Injury: 12,083
Malfunction: 6,561
Other: 1
Total: 18,694

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.