COMPORUS— 510(k) K062691

Substantially Equivalent

Takiron Co., Ltd.

FDA 510(k) clearance K062691 for COMPORUS, Substantially Equivalent on 2008-04-15. Applicant: Takiron Co., Ltd..

Clearance details

Applicant: Takiron Co., Ltd.
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2006-09-11
Decision date: 2008-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Himeji, Hyogo, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code MQV

product code MQV

Death: 6
Injury: 435
Total: 441

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.