DeviceClearance

K040756

Substantially Equivalent

THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX

Applicant
Implex Corp.
Product code
FTM
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Allendale, NJ, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FTM

product code FTM
Death
17
Injury
2,174
Total
2,191

Source: openFDA MAUDE database, through . 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.