Syntec Femoral Nail System— 510(k) K181296

Substantially Equivalent

Syntec Scientific Corporation

FDA 510(k) clearance K181296 for Syntec Femoral Nail System, Substantially Equivalent on 2019-04-11. Applicant: Syntec Scientific Corporation.

Clearance details

Applicant: Syntec Scientific Corporation
Product code: Code HSB
Advisory panel: Orthopedic
Date received: 2018-05-16
Decision date: 2019-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chang Hua, TW

Download summary PDF View on FDA.gov ↗

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.