OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM— 510(k) K073006

Substantially Equivalent

Takiron Co., Ltd.

FDA 510(k) clearance K073006 for OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM, Substantially Equivalent on 2008-05-29. Applicant: Takiron Co., Ltd..

Clearance details

Applicant: Takiron Co., Ltd.
Product code: 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

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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.