K073006

Substantially Equivalent

OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM

Applicant: Takiron Co., Ltd.
Product code: GWO
Advisory panel: Neurology
Date received: 2007-10-24
Decision date: 2008-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chuo-Ku, Kobe, Hyogo, JP

Adverse events under product code GWO

product code GWO

Malfunction: 583
Total: 583

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.