K202935

Substantially Equivalent

Syntec Femoral Nail Extended System

Applicant: Syntec Scientific Corporation
Product code: HSB
Advisory panel: Orthopedic
Date received: 2020-09-29
Decision date: 2020-10-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Chang Hua, TW

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.