THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX— 510(k) K040756

Substantially Equivalent

Implex Corp.

FDA 510(k) clearance K040756 for THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX, Substantially Equivalent on 2004-07-14. Applicant: Implex Corp..

Clearance details

Applicant: Implex Corp.
Product code: Code FTM
Advisory panel: General, Plastic Surgery
Date received: 2004-03-24
Decision date: 2004-07-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Allendale, NJ, US

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Adverse events under product code FTM

product code FTM

Death: 17
Injury: 2,174
Total: 2,191

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.