510(k) K221621— Pro-X1 Trochanteric Nailing System

Substantially Equivalent

X-Bolt Orthopedics

Clearance details

Applicant: X-Bolt Orthopedics
Product code: Code HSB
Advisory panel: Orthopedic
Date received: 2022-06-03
Decision date: 2023-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santry, IE

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.